MHRA medical device alert – Accu-Chek Insight insulin pumps – some need to be fitted with key frames

MHRA medical device alert – Accu-Chek Insight insulin pumps – some need to be fitted with key frames

February 19, 2019

MDA number: MDA/2019/009
Date issued 19th February 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert:

Problem

The key lock function of the pump locks only the buttons on the front of the insulin pump. It does not lock the quick bolus keys on the top of the pump.

The manufacturer has received reports of unintended boluses being delivered. Revised handling instructions were published in 2016 (MHRA issued MDA/2016/016) and now Roche Diabetes Care is providing users with key frames to fit onto all affected Accu-Check Insight pumps (i.e. pumps with serial numbers below 32100000) to further reduce the risk of accidental bolus delivery.

Action

  • Identify affected patients and pumps (serial numbers below 32100000)
  • Ensure that all patients and carers
  • a) receive a copy of manufacturer’s Field Safety Notice (FSN) and instructions for use dated December 2018.
  • b) understand the information detailed in the FSN
  • c) apply the new key frames as instructed by the manufacturer
  • Return the FSN acknowledgment form to Roche as currently they have not received enough responses

Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Deadlines for actions

Actions underway: 12 March 2019

Actions complete: 02 April 2019

Manufacturer contacts

Roche Diabetes Care

Tel: 0800 731 2291

burgesshill.insulinpumps@roche.com

Manufacturer FSCA Reference: SB_RDC_2015_05_2

 



Posted in:


More Latest News >

Ask PSNC: Flu FAQs

The team at PSNC has received a number of queries on the NHS Flu Vaccination Service 2019/20. Below are some...