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a alert imageSeptember 25 2017

Users of the Accu-Chek Insight insulin pumps are being asked to check their machines due to a possible problem with the alarm system. 

 The MHRA alert warns that “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.”

An electrical issue has been identified indicating there is a risk of a vibrator alarm failure and an intermittent audible alarm failure, says the MHRA. “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.”

Health professionals are being asked to identify any patients who may have the machine, which is made by Roche Diabetes Care, and 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 Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message.

Roche Diabetes Care can be contacted on 0800 731 2291 or via This email address is being protected from spambots. You need JavaScript enabled to view it..

Link:
MHRA alert        
MHRA Field Safety Notice             
Accu-Chek           

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