MEDICAL DEVICE ALERT – Accu-Chek® Insight insulin pump

A medical device alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding the risk of accidental activation of certain Accu-Chek® Insight insulin pumps

MEDICAL DEVICE ALERT

MDA/2019/009

19 February 2019

Accu-Chek® Insight insulin pump

(Manufactured by Roche Diabetes Care)

A medical device alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA)  to all healthcare professionals, including community pharmacy teams, regarding the risk of accidental activation of certain Accu-Chek® Insight insulin pumps.

Roche Diabetes Care has received reports of unintended boluses being delivered with the Accu-Chek® Insight insulin pump. Pumps with serial numbers below 32100000 have a key lock function that prevents accidental activation of buttons on the front of the device; however this function does not lock the quick bolus keys on the top of the device.

To reduce the risk of accidental bolus delivery, Roche Diabetes Care is now providing key frames to users that can be fitted onto all affected devices.

Action by pharmacy teams

• Identify all patients and pumps that have been affected (serial numbers below 32100000)
• Ensure that all patients and carers:
  • receive a copy of manufacturer’s Field Safety Notice (FSN) and instructions for use dated December 2018
  • understand the information detailed in the FSN
  • 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

 Timeframe for action

• Device Alert underway from: 12 March 2019
• Device Alert action complete: 02 April 2019

All adverse reactions need to be reported to the local incident reporting system and/or national incident reporting authority, as appropriate:

• England and Wales: Yellow Card website or Yellow Card App available on iOS devices and Android devices
• Northern Ireland: Northern Ireland Adverse Incident Centre (NIAIC) online form
• Scotland: Yellow Card website, Yellow Card App available on iOS devices and Android devices, or Incident Reporting and Investigation Centre (IRIC) (email iric@nhs.net to request a webform account)

Further information can be found on the MHRA section on the GOV.UK website.

Produced by NPA Pharmacy Services team February 2019.