SAFETY NOTICE, Accu-Check Spirit Combo.

[Pumper_Sue]

Accu-Chek Spirit Combo insulin pumps
Friday 16 January 2015


Roche Diabetes Care has issued a Safety Notice to advise users of the potential for the loss of date and time settings on the Accu-Chek- Spirit Combo insulin pump.

Roche Diabetes Care has become aware that in a limited number of cases, patients using the Accu-Chek Spirit Combo insulin pump may experience a loss of the date and time settings. A thorough investigation of the situation revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. The capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.

Given the rare case that the above mentioned issue occurs, this will result in the pump resetting to the default date and time and requiring the user to set or re-program the correct date and time on the pump. In such cases the user might accidentally overlook the change to the default date and time and confirm the default date and time settings provided by the pump. As a result, a shift of the basal rate time block would occur, which could potentially contribute to hyper- or hypoglycemic events. In users with impaired vision, it may be particularly difficult to detect the date and time loss.

Users of the Accu-Chek Spirit Combo insulin pump need to be aware of this issue and ensure time and date is set correctly on their pump after a battery change. Users who experience any failures associated with this issue should contact the Accu-Chek Customer Service Centre.

http://www.diabetes.org.uk/About_us...ion-on-Accu-Chek-Spirit-Combo-insulin-pumps/#

 

[Ellie Jones]

Accu-chek have also contacted all possible effected customers, I received a notice before christmas, only just go my pump. And had to feel out a form and send back in a prepaid envelope to confirm I'd received the information.

 

[trophywench]

Yes I had one too Ellie - but your meter beeps at you and sends you messages if the pump and meter don't agree on the time/date - if I change the wrong one first when we go abroad, or come back from, it's forever doing that. One assumes that, had that thing happened, it still would. Anyway mine has had a new battery in between the notice and now, and it's fine.

 

[ypauly]

Users who experience any failures associated with this issue should contact the Accu-Chek Customer Service Centre.

I did this a while back only to be told that as long as I dont take the batteries out of the remote/tester at the same time the information is backed up and it's just a case of resetting the time.

In short they were not really interested. Now I just reset time and date when I change the batteries. My concern was proving I had been testing should ever the police stop me while driving but as that info is on both devices all is ok.