MHRA Alert - Accu-Chek Spirit Combo insulin infusion pumps - all serial numbers.

[Northerner]

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON502575?tabName=Problem

Interrupting the pump’s power, eg to change the battery, may reset the default date and time. If this change goes unnoticed, and the user confirms the default settings, there will be a shift in the basal rate time block and this may affect insulin delivery. Patients with impaired vision are at particular risk as they may be less likely to notice the change.

 

[everydayupsanddowns]

Oops!

Wonder if they have fixed this on the Insight.

 

[Sally71]

Just done ours this morning and it's fine. Did actually get a notification from the hospital, but have just filed it as I usually check the time anyway when I've done a battery change. But have actually never had a problem.

Also the handset always synchronises its clock with the pump, and will beep and flash up a message if there is a difference of more than 5 minutes between the two, so that should alert you that something is amiss.

 

[trophywench]

I had a letter from Roche, a while ago now.

 

[HOBIE]

Could be a problem 😱

 

[heasandford]

Also the handset always synchronises its clock with the pump, and will beep and flash up a message if there is a difference of more than 5 minutes between the two, so that should alert you that something is amiss.

Unbelievably (because I wasn't aware) I had to change the battery this morning, with no problem. If you are checking your BG with the supplied meter then as stated by Sally71 it will alert you.

But I have to say this came as a bit of a shock to me, no notice from my hospital!

 

[trophywench]

I think it must only affect pumps made between date X and date Y or something cos mine doesn't do it and clearly neither does yours - and I haven't hear anyone say theirs does!

Do you order pump supplies yourself direct from Roche as I do? Maybe that's why I got the latter (well it was a notice not a letter) - thinking about it it might have been inside a box of cannulas etc I'd ordered.

 

[Sally71]

I order my supplies direct from Roche but actually got the notice via the hospital! It was the official Roche document, but some poor person at the hospital was phoning round everyone on their records with a Roche pump asking for email address to send the notification to. But they should have my email address on file anyway as I'm always contacting the DSN that way! Maybe they had to make sure that it was the right one in case I'd changed it recently

 

[Pumper_Sue]

I had already posted the notice on the 16th 🙂
http://diabetessupport.co.uk/boards/showthread.php?t=50912