The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for all Accu-Chek Insight insulin pumps (Roche Diabetes Care).
The alert advises that the audible and/or vibration alarms might not function on the pumps, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
The action points, which are to be completed by all healthcare workers responsible for patients who use these devices, are:
- identify all users of Accu-Chek Insight insulin pumps
- ensure that all patients and carers:
- receive the manufacturer’s Field Safety Notice (FSN)
- understand the information detailed in the FSN and follow the advice given by the manufacturer
- check the display of the insulin pump regularly
- seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary
- contact the Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message
- return the FSN acknowledgement form to Roche as currently the manufacturer has not received sufficient responses.
Deadline for actions:
- actions underway: 4th October 2017
- actions complete: 18th October 2017