Today a medical device alert was issued by the MRHA relating to the Accu-Chek® Spirit insulin pump. As Roche is in close contact with their customers all over the world through the respective sales representatives and Customer Service Centers, Roche received the information that, patients using the Accu-Chek Spirit insulin pump (up to serial number 10006093) in rare cases may experience a failure of their “up” and/or “down” buttons. These buttons are necessary to adjust the dosage of bolus insulin and to program basal rate profiles.

Given the rare case that the above mentioned failure occurs, this may result in reduced functionality of the insulin pump. In the unlikely event where both buttons cease to operate, the pump would not be capable of delivering a bolus nor be re-programmable. In this case, patients will 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.

There is no medical risk as the pump user is notified of the failing button function by the uncommon fact that he does not receive any visual or acoustic confirmation of the insulin pump for the successful bolus entry. Thus the user is aware of the failure and can act accordingly.

As patient safety is of utmost importance to Roche, the corrective steps to mitigate the malfunction have already been initiated, so that it can be ensured that all pumps with a serial number above 10006093 are unaffected and that this malfunction has been fully eliminated in all new Accu-Chek Spirit insulin pumps.

Furthermore, Roche Diagnostics informs Accu-Chek Spirit users and healthcare professionals comprehensively

• to raise the awareness for the potential malfunction in the respective product series and
• to ask the users to 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.

This medical device alert is intended to serve as thorough and comprehensive patient and healthcare professional information.

The low probability for this malfunction to occur is at approx. 5.3% of all Accu-Chek Spirit insulin pumps.

Customers with further enquiries should contact the Accu-Chek Insulin Pump Careline on (UK) 0800 731 2291 (ROI) 1800 882 351.