Medical safety alert – faulty insulin pump manufactured by Roche could lead to hypoglycaemic event

Posted: 16/05/2016

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety alert on 12 May 2016 about the Accu-Chek® Insight insulin pump system.  

There have been reports that a small number of people using the insulin pump system have noticed that the handset displayed the maintenance message M-83 “Pump not able to complete task”. Seeing this message, the users were unsure if the programmed task (eg a remote bolus sent from the handset to the pump) had been completed or not. 

The risk is that users will misinterpret this message and deliver a further dose, potentially resulting in a hypoglycaemic event. Users are advised to check pump history before re-initiating a programmed task. This will indicate whether the programmed task has been completed. If the insulin pump memory shows that the task has not been completed successfully, the task should be initiated again. As M-83 is a communication-related maintenance message, the insulin pump memory is the master device of the system that always shows the correct information of what actions have been completed. 

Elise Bevan, a solicitor in the product liability team at Penningtons Manches, said: “We suggest that patients contact their healthcare providers if they are uncertain. Healthcare providers have been asked to ensure that all patients and users understand the problem and the advice given by Roche. Our understanding is that Roche is in the process of updating the user manual for the Accu-Chek Insight handset to provide additional clarity on the M-83 maintenance message. An enhanced version of the user manual will be provided as soon as it is available.”

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