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MHRA device alert: Accu-Chek® Insight insulin pump system

Friday 2 September 2016

The MHRA have issued a warning about Accu-Chek® Insight insulin pump system. 

Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the ‘Key Lock’ function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.

Actions

The MHRA are asking health care professionals to identify users of the Accu-Chek Insight insulin pump system.Healthcare professionals should ensure that:

  • patients/carers understand that the Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are not locked by the Key Lock function
  • patients/carers receive a copy of manufacturer’sField Safety Notice (FSN), and are made aware of the enhanced handling instructions
  • all new patients/carers have a copy of the FSN with their Accu-Chek Insight pump system.
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