Issues with battery life of the Accu-Chek Insight insulin pumps

All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns.

The first warning for the medical device was issued on the 4^th August 2015 where Roche Diabetes Care, the medical manufacturers of the insulin pump, issued advice about the correct battery specifications and appropriate pump settings.

Warnings issued

In their urgent field safety notice, Roche Diabetes noted they’d received feedback from a number of people with diabetes using the Accu-Check insulin pump concerning the battery life on their devices quickly depleting, and the rapid battery depletion was also a cause of the device shutting down spontaneously.

Following a thorough investigation, Roche highlighted that, in these cases, there were low-quality batteries and/or incorrectly selected battery types for the insulin pump that caused the battery depletion and shutting down of the device.

To rectify this issue, Roche identified Energizer Ultimate Lithium, FR03, 1.5V AAA (FR03) or high-quality alkaline batteries (1.5V AAA (LR03)) as the recommended batteries when using the insulin pump. The medical manufacturer notes that these batteries have been successfully tested with the Accu-Chek Insight insulin pump.

The other recommendations include:

• Advising patients not to use carbon zinc or rechargeable nickel cadmium (NiCd/NiMH) batteries with the Acc-Chek Insight insulin pump and;
• Training patients to make sure to always confirm the correct battery type on the insulin pump upon the battery change.

May 2017 alert

The recommendations from 2015 seemingly weren’t sufficient enough to tackle the battery life issue as the MHRA issued an updated medical device alert on 2^nd May 2017. In this medical alert, Roche provided new instructions for enhancing the battery life of the insulin pumps. The letter acknowledged that users had been trained on how to change the battery of their insulin pumps, but the manufacturer noted it would like to add additional important measures that could actually improve the battery lifetime as well.

The letter doesn’t seem to contain anything new from the previous alert. They reiterate that choosing the wrong battery type when changing the batteries, or using low-quality batteries, can lead to rapid depletion of power or result in the system completely shutting off. The only new information that they seem to give is that a rapid voltage drop may prevent the insulin pump from giving out an alarm, which is crucial in notifying users to change their batteries. As a result of the alarm not sounding, there’s potentially a greater chance that not enough insulin will be delivered to the user.

The risk is heightened during night-time when the user is sleeping.

Actions

The MHRA has called for the following actions to be completed by the 6^th June 2017:

Ensure that all users and carers:

• Received the field safety notice dated 2^nd
• Understood the instructions detailed in the notice and follow the advice.
• Use the Energizer Ultimate lithium batteries (1.5V AAA/FR03) as well as follow the steps described in the handling instructions in the notice.

Roche has asked for those in receipt of the notice to return the acknowledgement form as the manufacturer hasn’t received enough responses.