Warning About Failing Insulin Infusion Pump, UK

Main Category: Diabetes
Article Date: 03 May 2009 - 0:00 PDT

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A medical device alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) relating to the Accu-Chek Spirit insulin pump.

People using the Accu-Chek Spirit insulin pump, up to serial number 10006093, may experience a failure of the device 'up' and/or 'down' buttons. These buttons are necessary to adjust the dosage of bolus insulin and to program basal rate profiles.

If this occurs, it may result in reduced functionality of the insulin pump. If both buttons cease to operate, the pump would not be capable of delivering a bolus nor be re-programmable. Users will then have to revert to a replacement pump or to an insulin pen device to deliver their bolus. The pump will continue to deliver the programmed basal insulin.

The MRHA states that there is no medical risk as pump users will become aware of the failing button function as the usual visual or acoustic confirmation of the insulin pump for the successful bolus entry fails to occur.

What to do if you are affected

Roche Diagnostics, who produce the device, are asking Accu-Chek Spirit users and healthcare professionals to:

- raise the awareness for the potential malfunction in the respective product series and
- report any occurring button malfunction to Roche customer service centers. In case an Accu-Chek Spirit insulin pump is affected by the above mentioned malfunction, Roche will immediately provide a replacement pump.

If you have concerns or for more information please contact Accu-Chek Insulin Pump Freephone Careline numbers:

- UK: 0800 731 2291
- ROI: 18 00 882351.

Source
Diabetes UK

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