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IMPORTANT: Product error on NovoPen® Echo® and/or NovoPen® 5

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Important safety information for people with diabetes in possession of NovoPen® Echo® and/or NovoPen® 5

PLEASE VIEW THE ATTACHED PDF DOCUMENT at base of thread for FULL details

Novo Nordisk A/S has detected that the insulin cartridge holder used in a number of NovoPen® Echo® and NovoPen® 5 batches may crack or break if exposed to certain chemicals in some household products, such as cleaning agents, sunscreen and food grease. NovoPen® Echo® and NovoPen® 5 are used for insulin treatment by people with diabetes. Novo Nordisk is already in contact with the MHRA regarding this.


Novo Nordisk urges people with diabetes using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk in order to replace the cartridge holder as some could be damaged.


A picture of the cartridge holder is shown in Figure 1.

upload_2017-7-5_16-7-34.png
Figure 1. Cartridge holder used for NovoPen® Echo® and NovoPen® 5.


Description of the problem:

If the cartridge holder comes in contact with certain chemicals it can crack or break. The reason for the cracking is that the plastic materials used for the cartridge holders in the affected batches can be weakened if exposed to certain chemicals found in some household products such as cleaning agents, sunscreen and food grease.

When cleaning the device as described in Instructions For Use, cracking of the cartridge holder is extremely unlikely.

Using a pen with a cracked/broken cartridge holder could result in the device delivering a smaller than intended insulin dose leading to an increase in blood sugar. The risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 %, i.e. only 1 in 1000 patients will experience high blood sugar due to an affected cartridge holder.


The warning symptoms of high blood sugar (hyperglycaemia) normally appear gradually and can be flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).


PLEASE VIEW THE ATTACHED PDF DOCUMENT (below) FOR DETAILS OF AFFECTED BATCHES AND WHAT TO DO IF YOU HAVE BEEN AFFECTED.
 

Attachments

Thanks for this. I will check both my pens
 
Bu***r, just checked mine and my in use one and my spare are both affected -typical!
Rang the customer helpline who were really good, they give you a web address to request new cartridge holders from - this is not the web address on the PDF above.
It is purely precautionary, and they say if you've had no problems you can keep using them until they send you the new cartridge holder.
However, I somehow seem to have acquired 3 Novopen echo 🙄, and the third is Ok, so I think I'll switch to that one.
 
Checked mine, it's OK, though I got it around the time they're saying, perhaps I got old stock!
 
Hi Hannah - I'm not type 1 and I don't use insulin but I want to thank you for bringing the said products to forum members notice. We all look out for each other on here. x
WL
 
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Both my pens have the affected lot numbers. I won't say they look in good order as I dont want to tempt fate. 🙂
Thanks for letting us know
 
Both of mine are in the affected range... thanks for post Hannah.
Replacements are now on order 🙂
 
Had an email today to say my two new cartridge holders are arriving tomorrow. Pretty good service as only ordered late yesterday afternoon 🙂
 
Hannah DUK said:
Important safety information for people with diabetes in possession of NovoPen® Echo® and/or NovoPen® 5

PLEASE VIEW THE ATTACHED PDF DOCUMENT at base of thread for FULL details

Novo Nordisk A/S has detected that the insulin cartridge holder used in a number of NovoPen® Echo® and NovoPen® 5 batches may crack or break if exposed to certain chemicals in some household products, such as cleaning agents, sunscreen and food grease. NovoPen® Echo® and NovoPen® 5 are used for insulin treatment by people with diabetes. Novo Nordisk is already in contact with the MHRA regarding this.


Novo Nordisk urges people with diabetes using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk in order to replace the cartridge holder as some could be damaged.


A picture of the cartridge holder is shown in Figure 1.

View attachment 3768
Figure 1. Cartridge holder used for NovoPen® Echo® and NovoPen® 5.


Description of the problem:

If the cartridge holder comes in contact with certain chemicals it can crack or break. The reason for the cracking is that the plastic materials used for the cartridge holders in the affected batches can be weakened if exposed to certain chemicals found in some household products such as cleaning agents, sunscreen and food grease.

When cleaning the device as described in Instructions For Use, cracking of the cartridge holder is extremely unlikely.

Using a pen with a cracked/broken cartridge holder could result in the device delivering a smaller than intended insulin dose leading to an increase in blood sugar. The risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 %, i.e. only 1 in 1000 patients will experience high blood sugar due to an affected cartridge holder.


The warning symptoms of high blood sugar (hyperglycaemia) normally appear gradually and can be flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).


PLEASE VIEW THE ATTACHED PDF DOCUMENT (below) FOR DETAILS OF AFFECTED BATCHES AND WHAT TO DO IF YOU HAVE BEEN AFFECTED.
Click to expand...
Hi Hannah

Just checked and both my pens have the same code.
I tried to open the PDF and just got gobldy gook on the screen.
I will try their website.
 
Sounds like its affecting a few of us. Chemicals ? Is it a type of polish or cleaner ? 😱
 
Wowser blimey Charlie who'd 'Ave thought!

Just picked up my new Novopen 5!

The cartridge holder on my old one had cracked and it was impossible to use, I even tried to use parts from an old 4 pen but didn't fit! Just read this and most mornings for a while I've been greasing up my boys with suntan lotion!! Who'd 'Ave thought! I assumed it was my heavy handedness!

Hey ho!
 
Thanks for posting this, @Hannah DUK - I've just checked my pens and they're both from the affected batches so I should probably get new cartridge holders, though I don't actually use any chemical products so mine are pretty unlikely to crack!

I don't suppose you - or anyone else - have an email address for Novo Nordisk? I can't use phones so will have to ask R to ring otherwise, and he makes more than enough phonecalls on my behalf!
 
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I'm using Novopen 4s so not upto to modern versions yet...
Cant you just take pens back to your G.P. or D Nurse and get them ?
 
Hannah , Sorry I meant can you not just change the faulty pens at your GP practice, be quicker I would of thought ?
 
I was interested to receive yesterday a telephone call from my surgery advising me that they had been told about this problem and needed me to take my pens in so they could check if they were in the relevant batches. They were surprised that I had already checked (thanks Forum!) and indeed had already got one new cartridge holder and changed it.
I wonder if they really had not been told until now, or they just take this long reading their post........
 
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