Getting very angry with Abbott over Libre 2.

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Pattidevans said:
It was time for a new sensor yesterday, so I uninstalled Librelink from my phone and installed version 2.5.3 which worked perfectly for me previously. I then started the sensor with my phone. I had thought I could also use the reader to read the phone if I did it right away, though I did not expect alarms on it, however, it's just telling me that I can't use the reader with the sensor as it has been started with anothr device. Although my phone is reading the sensor properly again I'm not now getting alarms. I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.

Anybody got any idea what phone settings I may need to tweak?
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How did you get the 2.5.3.version please
I informed my nurse and I an getting the Libra 3 ASAP alas I saw the email after she left for the Christmas period I have Hypo unawareness I have found rhe reader so will use that but it means changing the new sensor oh what fun it is to have tech and be diabetic lol I adore the DASH better than the Medtrum Nano
freesia said:
Surely they would have to as they're marketing it as having alarms. If someone hasn't got a libre reader and has no hypo awareness, it could be fatal. Are DUK onto them do we know?
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Pattidevans said:
Anybody got any idea what phone settings I may need to tweak?
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Not on Android (assuming notifications etc are enabled, including ‘time sensitive’ if that’s a thing on Robot?).

However, one possible glitch-solver is always to fully power the handset down and restart it.

Surprising how many times that half-joke of turn it off, turn it in again works!

Sorry you are still having such a runaround with this :(
 
I thought L2 was the same as L1, in that if you start it with the Reader, you can then also use your phone but that the alarms will only sound on the Reader and not on your phone. If you start it with phone, the Reader doesn't work at all.
 
Pattidevans said:
It was time for a new sensor yesterday, so I uninstalled Librelink from my phone and installed version 2.5.3 which worked perfectly for me previously. I then started the sensor with my phone. I had thought I could also use the reader to read the phone if I did it right away, though I did not expect alarms on it, however, it's just telling me that I can't use the reader with the sensor as it has been started with anothr device. Although my phone is reading the sensor properly again I'm not now getting alarms. I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.

Anybody got any idea what phone settings I may need to tweak?
Click to expand...
Hi @Pattidevans, the app you rolled back to 2.5.3 was released back in April 2021, at that time if you wanted to use a phone and a reader together you had to start the sensor with the reader, then set the phone as the second device (with alarms only available on the first device - the reader)

Here is a thread from April 2021 discussing this very issue:

For you @Pattidevans, your phone seems to be scanning your sensor via NFC correctly, but with no alarms, more like a Libre 1 sensor.
The alarms rely on your Bluetooth connection, and are a secondary feature. I don't use the Bluetooth alarms of Libre link, (I use xdrip+ with Libre 1 sensors) so I will have to pass that issue to the wider group.
 
It's all academic now because my phone decided all on it's own to update the app to the latest one (2.8.2) during the night. Alarms not working and sensor taking up to 4 minutes to show results of a scan. Phoned Abbott again as really this sensor is now useless. They are replacing it.... but only after I jumped through hoops with phone and LibreLink settings again. In the end the very pleasant customer services lady admitted that they know they have made a mess of the software, rather than blaming my phone, and she did reassure me that they are still working on an up date which they hope to release soon.

I said to her that the update was meant for people who use Novorapid pens and pointed out that they were actually a minority of T1s as many people use pumps and even those on injections do not all use those pens or NovoNordisk insulin. So whereas they may benefit, or not... the majority of us have been disadvantaged and that the internet is completely full of complaints (running to hundreds) about this last update. She asked if she could report my comments back. I said certainly.

I am somewhat mollified by her attitude.
 
Sorry about that @Pattidevans, there is a box to tick to turn off app updates on an app by app basis. In Google play go to your Librelink app and tap the 3 dots in the top right corner and remove the tick for auto updates.

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You should be able to uninstall the updated app and reinstall the older app, then turn off auto updates as shown above. As you are already using a new sensor the data in your Librelink app will start fresh, but will be available in Libreview on your PC.
 
Pattidevans said:
It's all academic now because my phone decided all on it's own to update the app to the latest one (2.8.2) during the night. Alarms not working and sensor taking up to 4 minutes to show results of a scan. Phoned Abbott again as really this sensor is now useless. They are replacing it.... but only after I jumped through hoops with phone and LibreLink settings again. In the end the very pleasant customer services lady admitted that they know they have made a mess of the software, rather than blaming my phone, and she did reassure me that they are still working on an up date which they hope to release soon.

I said to her that the update was meant for people who use Novorapid pens and pointed out that they were actually a minority of T1s as many people use pumps and even those on injections do not all use those pens or NovoNordisk insulin. So whereas they may benefit, or not... the majority of us have been disadvantaged and that the internet is completely full of complaints (running to hundreds) about this last update. She asked if she could report my comments back. I said certainly.

I am somewhat mollified by her attitude.
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@Pattidevans, when I spoke to one of various Abbott Customer Service people over the last couple of months, I was told a slightly different story about the Librelink updates.

Abbott have issued two updates. I was told the first update (which downloaded on my mobile mid November 2022) was supposed to "fix" some issues with alarms. I did query this with the person I spoke to at the time because I remember checking the Google Play store and it definately said the update was to allow users of these new smart insulin pens to communicate with and download insulin doses to Librelink.

The person I spoke to then said the second update (which my phone received on 1 December 2022) was supposed to allow these new Novo smartpens to communicate with Librelink..

I got new Novopen smart insulin pens recently (I had been using the same insulin pens that I got when I was first diagnosed decades ago and several good people on this forum suggested I really ought to get new pens). Anyone who uses Novo Nordisk insulin and needs a new durable insulin pen will now be prescribed a Novopen smartpen.

They are very useful. I pride myself on having an excellent memory, but sometimes even I forget when I last injected and the number of units.

But I really, really, really, need the Librelink alarms on my mobile to work again properly. Soon!

I've also put on and had to take off four Libre 2 sensors in a row over 96 hours because I couldn't get high and low glucose alarms on my brand new Libre 2 Reader. All four Libre 2 sensors were faulty.

I'm just very thankful I'm hypo aware. Have read at least two accounts elsewhere - one of which involved a child - where Librelink alarms didn't go off, the users went into severe hypoglycaemia and in one case the user woke up to paramedics treating them (with all the potential implications that has if one drives and one wants to keep one's driver's licence).

I read in an earlier post that you were thinking of contacting DUK to see if they might contact NHS England to encourage Abbott to sort the problems out. I was wondering if you spoke to anyone at DUK.

I am now thinking seriously about reporting the problems I've had to the MHRA as a Yellow Card incident. The MHRA really will make Abbott sort this mess out pronto.
 
BadaBing said:
I am now thinking seriously about reporting the problems I've had to the MHRA as a Yellow Card incident.
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I personally think you should report your problems as a yellow card incident and believe others should also do this.
BadaBing said:
The MHRA really will make Abbott sort this mess out pronto.
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I'm far from confident that the MHRA will sort this out pronto, particularly if your report is an isolated incident. Whereas I strongly suspect the MHRA will need a modest barrage of complaints, before they sit up and pay attention.

The harsh reality is that there is no evidence that the NHS manager for this highish value contract is in any way informed about the myriad of defective Libre sensors - not least because that contract manager is not in the information loop for defect reporting and Google searches have not revealed to me who, by job title if not personal name, that contract manager is or where based.

I have said before, the change in legislation in respect of the Sale of Goods Act moved the responsibility for faulty goods from the manufacturing source or wholesale supplier to the seller. At very first glance that seemed contradictory (why burden retailers with problems from manufacturers?) but after a moment's thought it made great sense. If a retailer has lots of complaints about the goods they are selling they will stop retailing these and that makes it far more evident to manufacturers about the business they are losing: they then either improve (and have to convince their lapsed retailer that they have improved, or that product sinks (perhaps with the manufacturer). This is market forces at their best.

Other Gov't or public interest contracts are normally subject to Treasury rules, which includes a clear audit trail that the Contract Manager is closely monitoring the performance of their Contract, with regular reviews and close scrutiny of supply or service delivery to the end-users. There is no evidence this is occurring with Abbott and the Freestyle Libre sensors.

Pertinent questions to anyone's MP might attract attention - such as : Given there is some evidence of consistent failures and problems with software from Libre 2, does the Public Accounts Committe know about these? Is scrutiny of NHS higher value contracts in the purview of the PCA? Is the Secretary of State for Health aware that there are underlying problems? Are NICE aware of these problems? Could the MP provide an email address for the Contract Manager for these sensors, so that they can at least be informed of this serious medical issue? Such questions could be presented individually to the relevant responsible person - but I suspect more headway would be gained from an MP taking the initiative; it might take a little longer to get the scrutiny started, but would allow an MP to bask in their initiative to get this resolved and would suit most MP's egos!
 
Proud to be erratic said:
I personally think you should report your problems as a yellow card incident and believe others should also do this.

I'm far from confident that the MHRA will sort this out pronto, particularly if your report is an isolated incident. Whereas I strongly suspect the MHRA will need a modest barrage of complaints, before they sit up and pay attention.

The harsh reality is that there is no evidence that the NHS manager for this highish value contract is in any way informed about the myriad of defective Libre sensors - not least because that contract manager is not in the information loop for defect reporting and Google searches have not revealed to me who, by job title if not personal name, that contract manager is or where based.

I have said before, the change in legislation in respect of the Sale of Goods Act moved the responsibility for faulty goods from the manufacturing source or wholesale supplier to the seller. At very first glance that seemed contradictory (why burden retailers with problems from manufacturers?) but after a moment's thought it made great sense. If a retailer has lots of complaints about the goods they are selling they will stop retailing these and that makes it far more evident to manufacturers about the business they are losing: they then either improve (and have to convince their lapsed retailer that they have improved, or that product sinks (perhaps with the manufacturer). This is market forces at their best.

Other Gov't or public interest contracts are normally subject to Treasury rules, which includes a clear audit trail that the Contract Manager is closely monitoring the performance of their Contract, with regular reviews and close scrutiny of supply or service delivery to the end-users. There is no evidence this is occurring with Abbott and the Freestyle Libre sensors.

Pertinent questions to anyone's MP might attract attention - such as : Given there is some evidence of consistent failures and problems with software from Libre 2, does the Public Accounts Committe know about these? Is scrutiny of NHS higher value contracts in the purview of the PCA? Is the Secretary of State for Health aware that there are underlying problems? Are NICE aware of these problems? Could the MP provide an email address for the Contract Manager for these sensors, so that they can at least be informed of this serious medical issue? Such questions could be presented individually to the relevant responsible person - but I suspect more headway would be gained from an MP taking the initiative; it might take a little longer to get the scrutiny started, but would allow an MP to bask in their initiative to get this resolved and would suit most MP's egos!
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Merry Christmas @Proud to be erratic. I hope you are enjoying the festive season.

Had to break off to respond to your post.

Because of my job, I know a little bit more than the average UK consumer about how medicines and medical devices obtain approval to be supplied to the public in this (and other) countries.

Pharmaceutical products and medical devices are regulated in the United Kingdom, as they are in the European Union (by the European Medicines Agency), the USA (by the US Food and Drug Administration) and every other mature democracy.

Because drugs and medical devices are regulated, they are a special category of goods. The regulatory regime is there to add an extra umbrella of protection for the public at large beyond that given by usual consumer protection legislation. It allows the regulators to order products are taken off the market, if necessary with immediate effect, and for products to be recalled, if those products are found no longer to be work or be safe.

It is the responsibility of medical regulators in each country to approve and licence the use of drugs and medical devices to patients.

The Medicines and Healthcare Products Regulatory Agency ("MHRA") is an agency of the Department of Health and Social Care. It was set up by the Blair government in 2003. It replaced the old medicines controls agency and the medical devices agency.

The MHRA authorises and licences drugs and medical devices for sale and prescription and use by the public in the United Kingdom.

In the United Kingdom it is the exclusive remit of the MHRA to certify that every drug and medical device sold over the counter (or online) or provided on via prescription in the UK (a) works and (b) is safe. The MHRA has the power to revoke any licence for any drug or medical device if that drug or medical device ceases to work or be safe.

All mature democracies with a medical regulator have a process in place to allow healthcare professionals, or individuals who use drugs or medical devices, to report adverse events that are believed to be caused by the use of any drug or medical device. In the UK that process is the Yellow Card System.

Of course it is trite to say a single yellow card report sent into the MRHA is unlikely to result in the MHRA taking action. Which is why other people need to report issues too if they believe the current issues with the Librelink app or faulty sensors have "caused, or almost caused, an injury to a patient or other person, or a wrong or delayed diagnosis and treatment of a patient" [from the MHRA's own website].

I am a fan of getting one's member of Parliament involved in issues IF I think it is appropriate and proportional to do so and IF it is likely to have the desired effect.

However, there are laws, rules, regulations which the MHRA must follow and their decision-making process must always be based on evidence and never on any one UK member of parliament "getting involved." If the MHRA were to fail to follow the laws, rules and regulations that govern what they do, and the evidence, then any decision the MHRA make to revoke a licence or withdraw products would almost certainly be subject to successful challenge through the courts by judicial review.

That's how the process works in the UK. And rightly so.

As I have said in other posts, I suspect very few people have raised yellow card events with the MHRA so far. They haven't done so because - just as I have - they have trusted Abbott to fix the problems quickly or send out replacement sensors.

I say again, I have read accounts on other forums of individuals who say they have suffered severe hypoglycaemia because they were relying on receiving an alarm from Librelink on their mobile phones before their sugars went too low. Alarms which never happened since the Librelink app was updated 6/7 weeks ago. And at least one of the individuals whose accounts I read say they had to be treated by paramedics as a result.

I don't intend to contact my MP about the issues I've had. I know my MP sufficiently well to know that they simply won't be interested unless I had gone into a diabetic coma (which thankfully I haven't thus far), and therefore it would be a complete waste of my and their time.

I would rather send a yellow card report into the MHRA and trust that others will do so too.

As for whomever "the NHS manager is who is responsibile for the high value contract with Abbott," that is wholly irrelevant to the MHRA's role and responsibility in law for ensuring drugs and medical devices work and are safe.

The fact that the relevant NHS manager responsible for the high value contract is not aware of what is going on (I know I - and others - have reported our experiences to our diabetes clinicians - if those clinicians have failed to pass that information onto anyone higher up the NHS "foodchain," then there is something very wrong within the NHS's reporting systems that must be fixed) should not stop anyone reporting a Yellow Card event if they think it is appropriate to do so.

Happy New Year!
 
Chatgpt:

Here is a summary of the regulatory process for drugs and medical devices in the UK:

  • The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for approving and licensing the use of drugs and medical devices in the UK.
  • The MHRA has the power to revoke any license for a drug or medical device if it is found to be unsafe or ineffective.
  • The Yellow Card System allows individuals to report adverse events that they believe may be related to the use of a drug or medical device.
  • If a problem with a drug or medical device is reported, the MHRA may take action, such as revoking a license or ordering a recall, based on the evidence and following the laws, rules, and regulations that govern its actions
 
BadaBing said:
Merry Christmas @Proud to be erratic. I hope you are enjoying the festive season.

Had to break off to respond to your post.
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Hello @BadaBing, I certainly am enjoying the festivities; just wish I could keep my BG down - it is determined to bounce me back into the mid teens by the end of each 4 hr correction period. Even a particularly aggressive correction yesterday, followed by an enjoyable walk with my grandson and which got me into the 4's, was back in the teens 4 hrs later. Changed my insulin batch, raised my basal, running out of ideas. But that's for another day. I'm awake early now, to take another correction.
BadaBing said:
Because of my job, I know a little bit more than the average UK consumer about how medicines and medical devices obtain approval to be supplied to the public in this (and other) countries.
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I'm happy to bow to your much deeper knowledge about the process below.
BadaBing said:
Pharmaceutical products and medical devices are regulated in the United Kingdom, as they are in the European Union (by the European Medicines Agency), the USA (by the US Food and Drug Administration) and every other mature democracy.

Because drugs and medical devices are regulated, they are a special category of goods. The regulatory regime is there to add an extra umbrella of protection for the public at large beyond that given by usual consumer protection legislation. It allows the regulators to order products are taken off the market, if necessary with immediate effect, and for products to be recalled, if those products are found no longer to be work or be safe.

It is the responsibility of medical regulators in each country to approve and licence the use of drugs and medical devices to patients.

The Medicines and Healthcare Products Regulatory Agency ("MHRA") is an agency of the Department of Health and Social Care. It was set up by the Blair government in 2003. It replaced the old medicines controls agency and the medical devices agency.

The MHRA authorises and licences drugs and medical devices for sale and prescription and use by the public in the United Kingdom.

In the United Kingdom it is the exclusive remit of the MHRA to certify that every drug and medical device sold over the counter (or online) or provided on via prescription in the UK (a) works and (b) is safe. The MHRA has the power to revoke any licence for any drug or medical device if that drug or medical device ceases to work or be safe.

All mature democracies with a medical regulator have a process in place to allow healthcare professionals, or individuals who use drugs or medical devices, to report adverse events that are believed to be caused by the use of any drug or medical device. In the UK that process is the Yellow Card System.

Of course it is trite to say a single yellow card report sent into the MRHA is unlikely to result in the MHRA taking action.
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I presume you meant likely rather than unlikely.
BadaBing said:
Which is why other people need to report issues too if they believe the current issues with the Librelink app or faulty sensors have "caused, or almost caused, an injury to a patient or other person, or a wrong or delayed diagnosis and treatment of a patient" [from the MHRA's own website].
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And I agreed with this in my earlier posting. Although I have a unsatisfactory relationship with Libre 2, I feel almost certainly "it is me" and my body doesn't like Libre 2 so I don't think I can justify a yellow card report. The only leverage I mightbhave is that my Consultant has asked my GP to write a script for Dexcom One and my GP has written to me saying they cannot write that script, since the BOB ICS has not yet approved Dexcom One. So I could reason that I am getting a wrong treatment from Libre 2, with my fully documented history of 50% failures and neglect by my ICS in not recognising that a low/no cost option is available from the NHS Formulary - solely because my ICS is being tardy in implementing the simple enough update to NICE Guidance Note NG19.
I just think this is stretching reasonability; Abbott have replaced all defective sensors; I have specifically agreed with each replacement request that I was not put at medical risk and did not need extra medical attention. I've just been inconvenienced.
So I guess I need to try a different path to the Yellow brick road ....
BadaBing said:
I am a fan of getting one's member of Parliament involved in issues IF I think it is appropriate and proportional to do so and IF it is likely to have the desired effect.
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I recognise the 2 IFs.
My MP is a Lib Dem who gained an otherwise seemingly safe Conservative seat after a by-election and benefitted from a knee-jerk response to Boris's misbehaviour during Covid. If the letter box drops are indicative of my MP's determination to improve UK Politics, then the right letter to her might trigger some action. But I also recognise the reality that it might not catch her attention.
I'm still mulling over my options and at risk of confusing myself, never mind my MP. I guess my real problem is that our regional ICS is just invisible; it was quoted by my GP in her written response to me telling me she can't write the script for Dexcom One. But no-one (not my GP, nor the PALs for the ICS, nor the S Bucks Hospice that has been kindly monitoring and helping me post Chemo) can provide a specific structure for the BOB ICS, or a contact phone no or email address within the ICS. Everyone says the ICS hasn't yet approved Dexcom One, no-one can be specific about who or what is in the ICS. It makes George Orwell's vision of the future so true; or the Yes Minister TV series has become alarmungly phrophetic. Probably hundreds of people working in the name of an ICS that has a title, but no substance.
BadaBing said:
However, there are laws, rules, regulations which the MHRA must follow and their decision-making process must always be based on evidence and never on any one UK member of parliament "getting involved." If the MHRA were to fail to follow the laws, rules and regulations that govern what they do, and the evidence, then any decision the MHRA make to revoke a licence or withdraw products would almost certainly be subject to successful challenge through the courts by judicial review.

That's how the process works in the UK. And rightly so.

As I have said in other posts, I suspect very few people have raised yellow card events with the MHRA so far. They haven't done so because - just as I have - they have trusted Abbott to fix the problems quickly or send out replacement sensors.

I say again, I have read accounts on other forums of individuals who say they have suffered severe hypoglycaemia because they were relying on receiving an alarm from Librelink on their mobile phones before their sugars went too low. Alarms which never happened since the Librelink app was updated 6/7 weeks ago. And at least one of the individuals whose accounts I read say they had to be treated by paramedics as a result.

I don't intend to contact my MP about the issues I've had. I know my MP sufficiently well to know that they simply won't be interested unless I had gone into a diabetic coma (which thankfully I haven't thus far), and therefore it would be a complete waste of my and their time.

I would rather send a yellow card report into the MHRA and trust that others will do so too.

As for whomever "the NHS manager is who is responsibile for the high value contract with Abbott," that is wholly irrelevant to the MHRA's role and responsibility in law for ensuring drugs and medical devices work and are safe.
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I do wonder about whether it is irrelevant to the MHRA role and responsibility. How, exactly, does the MHRA raise a concern to a Supplier of a possible dangerous medication? Surely, apart from approaching Abbott with their evidence, they must involve or inform the NHS or the Dep't of Health that they are investigating something. Is there a Protocol that the MHRA must, or should, follow and is that protocol in the public domain? If the MHRA were formerly ISO 9000 accredited, they would have been obliged to tell the originator of the Yellow Card something about their response (although the cynic in me thinks that feedback would be vague and obscure - the public doesn't really need to know how the MHRA conducts its business, in case the public takes too much interest!)
BadaBing said:
The fact that the relevant NHS manager responsible for the high value contract is not aware of what is going on (I know I - and others - have reported our experiences to our diabetes clinicians - if those clinicians have failed to pass that information onto anyone higher up the NHS "foodchain," then there is something very wrong within the NHS's reporting systems that must be fixed)
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Agreed: from talking with a DSN on my recent DAFNE course I couldn't help feeling there is a lot wrong with the reporting chain, partly because staff feel overloaded and burdened with immediate patient issues in front of them; and partly because there is not that instinctive sense 'if you see something that is wrong and you walk on by, you condone that wrong and thus approve that wrong'. But I also know that is the easy bit - the difficult bit is how to correct that wrong in a timely, sensible and appropriate way.
BadaBing said:
should not stop anyone reporting a Yellow Card event if they think it is appropriate to do so.
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Agreed.
BadaBing said:
Happy New Year!
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And a Happy New Year to yourself.
 
Proud to be erratic said:
I presume you meant likely rather than unlikely.
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No, I meant what I said. If only one person reports an MHRA Yellow Card incident, the MHRA is unlikely to do anything. But if many people do, I would expect the MHRA at the very least to engage with Abbott to make them resolve the issues many people have complained about.

The Libre 2 has been licensed by the MHRA to provide low and high glucose alarms via the Librelink app on a compatible mobile phone. At the moment Librelink is failing to do so on many people's compatible phones. Some people rely on those alarms. I know I do to treat hyperglycaemia in a timely way to minimise diabetes complications happening in the medium and longer term
Proud to be erratic said:
And I agreed with this in my earlier posting. Although I have a unsatisfactory relationship with Libre 2, I feel almost certainly "it is me" and my body doesn't like Libre 2 so I don't think I can justify a yellow card report. The only leverage I mightbhave is that my Consultant has asked my GP to write a script for Dexcom One and my GP has written to me saying they cannot write that script, since the BOB ICS has not yet approved Dexcom One. So I could reason that I am getting a wrong treatment from Libre 2, with my fully documented history of 50% failures and neglect by my ICS in not recognising that a low/no cost option is available from the NHS Formulary - solely because my ICS is being tardy in implementing the simple enough update to NICE Guidance Note NG19.
I just think this is stretching reasonability; Abbott have replaced all defective sensors; I have specifically agreed with each replacement request that I was not put at medical risk and did not need extra medical attention. I've just been inconvenienced.
So I guess I need to try a different path to the Yellow brick road ....
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Whether a particular flash glucose monitor or continuous glucose monitor performs reasonably well for any given individual depends on a number of factors, including whether that particular medical device works well with the individual's own body chemistry.

I'm very lucky in that the Freestyle Libre system sensors (when it works) works extremely well with my own body chemistry and give readings which are within the working parameters of the Libre system when compared to a blood fingerstick test. It is one of the reasons why despite the frustrations of the last few weeks, I prefer to continue using the Freestyle Libre system.

But Abbott need to fix the issues of Librelink alarms failing to go off on mobile phones, and too high a failure rate of Libre 2 sensors, because I believe those problems have delayed me diagnosing and treating hypoglycaemia and hyperglycaemia in a timely way.

The issue you mention with the various integrated care systems/integrated care boards (the former clinical commissioning groups) not making other manufacturers' flash and continuous glucose monitoring products available in the health regions the ICS/ICB (former CCGs) are responsible for, despite the change to NICE guidance in April 2022 - and the edict that was issued by NHS England in August 2022 to make other third party flash and continuous glucose products available - is an entirely separate issue.

It has more to do with (a) ICSs/ICBs claiming they don't have the time and resources to train staff to educate diabetic patients to use the new third party flash glucose monitors and continuous glucose monitors that are available, and (b) an unwillingness - however wrongheaded and pennywise-but-pound-foolish - by ICSs/ICBs to spend money on the new third party flash glucose monitors and continuous glucose monitors for fear that doing so will eat up a disproportionate amount of their budgets (which budgets they are required by law to balance every year, just as local councils have to balance their budgets annually).
Proud to be erratic said:
I recognise the 2 IFs.
My MP is a Lib Dem who gained an otherwise seemingly safe Conservative seat after a by-election and benefitted from a knee-jerk response to Boris's misbehaviour during Covid. If the letter box drops are indicative of my MP's determination to improve UK Politics, then the right letter to her might trigger some action. But I also recognise the reality that it might not catch her attention.
I'm still mulling over my options and at risk of confusing myself, never mind my MP. I guess my real problem is that our regional ICS is just invisible; it was quoted by my GP in her written response to me telling me she can't write the script for Dexcom One. But no-one (not my GP, nor the PALs for the ICS, nor the S Bucks Hospice that has been kindly monitoring and helping me post Chemo) can provide a specific structure for the BOB ICS, or a contact phone no or email address within the ICS. Everyone says the ICS hasn't yet approved Dexcom One, no-one can be specific about who or what is in the ICS. It makes George Orwell's vision of the future so true; or the Yes Minister TV series has become alarmungly phrophetic. Probably hundreds of people working in the name of an ICS that has a title, but no substance.
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If you live in a constituency with an MP who is empathetic and prepared to engage with you, I truly envy you. Unfortunately I don't! And I am not prepared to risk diabetic coma (with all the attendant medical risks of possible brain and other organ damage) to get my MP's attention.
Proud to be erratic said:
I do wonder about whether it is irrelevant to the MHRA role and responsibility. How, exactly, does the MHRA raise a concern to a Supplier of a possible dangerous medication? Surely, apart from approaching Abbott with their evidence, they must involve or inform the NHS or the Dep't of Health that they are investigating something. Is there a Protocol that the MHRA must, or should, follow and is that protocol in the public domain? If the MHRA were formerly ISO 9000 accredited, they would have been obliged to tell the originator of the Yellow Card something about their response (although the cynic in me thinks that feedback would be vague and obscure - the public doesn't really need to know how the MHRA conducts its business, in case the public takes too much interest!)
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Because the laws of this country, the laws made by UK Parliament, give the MHRA the legal powers to revoke a licence for the sale to the public of any drug or medical device made available to the public, and to mandate that a particular drug or medical device is no longer sold and taken immediately off shelf and/or recalled.

There are significant penalties for any pharmaceutical company, medical device manufacturer and retailers who fail to comply IF the MHRA decides to revoke a licence and mandates product be removed.

That's why.

The only other institution in the UK that has that sort of power is one of His Majesty's judges following legal action.

I say once again the MHRA is an executive agency of the Department of Health and Social Care. It's part of the NHS.
Proud to be erratic said:
Agreed: from talking with a DSN on my recent DAFNE course I couldn't help feeling there is a lot wrong with the reporting chain, partly because staff feel overloaded and burdened with immediate patient issues in front of them; and partly because there is not that instinctive sense 'if you see something that is wrong and you walk on by, you condone that wrong and thus approve that wrong'. But I also know that is the easy bit - the difficult bit is how to correct that wrong in a timely, sensible and appropriate way.
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All any of us can do is trust that our clinicians will do the right thing, not dismiss concerns we report to them as trivial, and inform the right people up the chain of command about our concerns.

However, each of us as patients has the power and agency - through the MHRA's Yellow Card Scheme - to do our bit (our moral/public/community duty?) and report to the MHRA concerns to try to ensure all medicines and medical devices on the market in the UK (a) work and (b) are and remain safe.
Proud to be erratic said:
And a Happy New Year to yourself.
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And to you!
 
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Proud to be erratic said:
Hello @BadaBing, I certainly am enjoying the festivities; just wish I could keep my BG down - it is determined to bounce me back into the mid teens by the end of each 4 hr correction period. Even a particularly aggressive correction yesterday, followed by an enjoyable walk with my grandson and which got me into the 4's, was back in the teens 4 hrs later. Changed my insulin batch, raised my basal, running out of ideas. But that's for another day. I'm awake early now, to take another correction.

I'm happy to bow to your much deeper knowledge about the process below.

I presume you meant likely rather than unlikely.

And I agreed with this in my earlier posting. Although I have a unsatisfactory relationship with Libre 2, I feel almost certainly "it is me" and my body doesn't like Libre 2 so I don't think I can justify a yellow card report. The only leverage I mightbhave is that my Consultant has asked my GP to write a script for Dexcom One and my GP has written to me saying they cannot write that script, since the BOB ICS has not yet approved Dexcom One. So I could reason that I am getting a wrong treatment from Libre 2, with my fully documented history of 50% failures and neglect by my ICS in not recognising that a low/no cost option is available from the NHS Formulary - solely because my ICS is being tardy in implementing the simple enough update to NICE Guidance Note NG19.
I just think this is stretching reasonability; Abbott have replaced all defective sensors; I have specifically agreed with each replacement request that I was not put at medical risk and did not need extra medical attention. I've just been inconvenienced.
So I guess I need to try a different path to the Yellow brick road ....

I recognise the 2 IFs.
My MP is a Lib Dem who gained an otherwise seemingly safe Conservative seat after a by-election and benefitted from a knee-jerk response to Boris's misbehaviour during Covid. If the letter box drops are indicative of my MP's determination to improve UK Politics, then the right letter to her might trigger some action. But I also recognise the reality that it might not catch her attention.
I'm still mulling over my options and at risk of confusing myself, never mind my MP. I guess my real problem is that our regional ICS is just invisible; it was quoted by my GP in her written response to me telling me she can't write the script for Dexcom One. But no-one (not my GP, nor the PALs for the ICS, nor the S Bucks Hospice that has been kindly monitoring and helping me post Chemo) can provide a specific structure for the BOB ICS, or a contact phone no or email address within the ICS. Everyone says the ICS hasn't yet approved Dexcom One, no-one can be specific about who or what is in the ICS. It makes George Orwell's vision of the future so true; or the Yes Minister TV series has become alarmungly phrophetic. Probably hundreds of people working in the name of an ICS that has a title, but no substance.

I do wonder about whether it is irrelevant to the MHRA role and responsibility. How, exactly, does the MHRA raise a concern to a Supplier of a possible dangerous medication? Surely, apart from approaching Abbott with their evidence, they must involve or inform the NHS or the Dep't of Health that they are investigating something. Is there a Protocol that the MHRA must, or should, follow and is that protocol in the public domain? If the MHRA were formerly ISO 9000 accredited, they would have been obliged to tell the originator of the Yellow Card something about their response (although the cynic in me thinks that feedback would be vague and obscure - the public doesn't really need to know how the MHRA conducts its business, in case the public takes too much interest!)

Agreed: from talking with a DSN on my recent DAFNE course I couldn't help feeling there is a lot wrong with the reporting chain, partly because staff feel overloaded and burdened with immediate patient issues in front of them; and partly because there is not that instinctive sense 'if you see something that is wrong and you walk on by, you condone that wrong and thus approve that wrong'. But I also know that is the easy bit - the difficult bit is how to correct that wrong in a timely, sensible and appropriate way.

Agreed.

And a Happy New Year to yourself.
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I think in your case, where it is a different issue of your GP is unable to prescribe a medically recommended "treatment" due to delays by the ICS/ICB it is entirely appropriate to write to your MP - as a "local issue" pressure from your MP may well have the desired outcome!
 
This is a big read of which I've only done a fast read. This is my set up.
I'm using L2 but use Libreview to read L2 back and glooko for my Omni pump back to my Diabetic nurse.
I start my L2 sensor with its PDM first followed by my phone. The alarms ONLY sound on the pdm. I have noticed that I get more "try again in 10 mins" errors of late but in general both systems work well.

That said in January coming I am due to change over to Dexcom G7, after in house training, by recommendation of my diabetic nurse. They are expecting to do this for many if not all present L2 users. I'm in Wyre Forest Geo area.
I've had a quick look-see and the Dexcom has a much better looking customer support interface, but then I've not yet spoke with them on any problems so time will tell.

Best
 
mark king said:
This is a big read of which I've only done a fast read. This is my set up.
I'm using L2 but use Libreview to read L2 back and glooko for my Omni pump back to my Diabetic nurse.
I start my L2 sensor with its PDM first followed by my phone. The alarms ONLY sound on the pdm. I have noticed that I get more "try again in 10 mins" errors of late but in general both systems work well.

That said in January coming I am due to change over to Dexcom G7, after in house training, by recommendation of my diabetic nurse. They are expecting to do this for many if not all present L2 users. I'm in Wyre Forest Geo area.
I've had a quick look-see and the Dexcom has a much better looking customer support interface, but then I've not yet spoke with them on any problems so time will tell.

Best
Click to expand...
Thanks @mark king. As far as I can tell, Dexcom One is a fairly different 'beast' to G7 and that is reflected in the greater unit price of G7; arguably more akin to comparing apples and oranges (both edible fruits, yet pretty different). Over this seasonal break I'm going to do more research, hunt down you tube videos to fill in the gaps that the Dexcom site doesn't seem to provide.

I like having alarms on my L2 reader and for quick Libre scans; with my android phone for recording data such as insulin and carbs. I understand the Dexcom One Reader is very basic; but I admit I've not fully researched that - and I understand I'm likely to need a specific app for recording data, which can be visible to a 3rd party, such as the DSN team. I'm not clear if the Dexcom app Clarity will do that. So lots of holes in my knowledge at present.

Meanwhile I've opened up various 'rabbit holes' and need to pause and decide which way to turn, ie where to put my maximum effort in deciding how to proceed. I'm slightly confusing myself with too many possible options, none of which at the moment seem ideal for my making real progress. However, all of this is going further away from the original topic of "Abbott and unsatisfactory Libre 2" and apologies for adding to the digression.
 
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