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21 September 2017 by Hilary Cunningham

Medical device alert: All Accu-Chek Insight Insulin pumps - risk of alarm failure

  • Wales
  • England
  • Scotland
  • Northern Ireland

Accu-Chek Insight pumps (manufactured by Roche Diabetes Care) - 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.

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.

Action

  • 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 Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message
  • Return the FSN acknowledgment form to Roche as currently the manufacturer has not received sufficient responses

Deadlines for actions

Actions underway: 4 October 2017

Actions complete: 18 October 2017

Manufacturer contacts

Roche Diabetes Care

Tel: 0800 731 2291

burgesshill.insulinpumps@roche.com

Manufacturer FSCA Reference: SB_RDC_2017_04

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