MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – risk of alarm failure

20 September 2017

Roche Accu-Chek Insight insulin pumps – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.

All patients and carers using the Accu-Chek Insight insulin pump will receive the manufacturer’s Field Safety Notice (FSN).

Pump users should check the display of the insulin pump regularly and:

  • seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary
  • contact Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message
  • return the FSN acknowledgment form (sent by Roche to all Insight users) to Roche as currently the manufacturer has not received sufficient responses

Problem / background

Due to an electrical issue there is a risk of a vibrator alarm failure and an intermittent audible alarm failure.

The alarm failures will be detected during a pump’s self-test, which is prompted by changing the battery or insulin cartridge. If the failures are detected, the E7 error shows on the pump’s display.

Users should contact the customer careline as instructed in the user manual if they cannot resolve an E7 error message.

Manufacturer contacts
Roche Diabetes Care
Tel: 0800 731 2291

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