Medical device alert issued for Accu-Chek Insight insulin pump system
May 16 2016
An alert warning of a potential risk of hypoglycaemic event has been issued in relation to the Accu-Chek Insight insulin pump system.
Problems may arise with misinterpreting a maintenance message on the device, manufactured by Roche Diabetes Care. If the message says ‘M-83 pump not able to complete task’, users are advised to check the pump history before re-initiating a programmed task such as bolus delivery, said the medicines and device regulator, the MHRA.
If not, there is a risk that they may repeat the programmed task resulting in receiving a further dose.
It is asking that all patients and users are made aware of the problem and have received the manufacturer’s Field Safety Notice. In addition people supplying the pump should also include a copy of the Field Safety Notice and draw user’s attention to it.
Roche Diabetes Care is updating the instruction booklet to reflect the advice given in the Field Safety Notice.