Source: Medicines & Healthcare products & Regulatory Agency (MHRA)
On the 19th of February 2019, MHRA issued a Medical Device Alert for Accu-Chek Insight insulin pumps manufactured by Roche Diabetes Centre. The alert is in regards to insulin pumps needing to be fitted with keyframes to reduce the risk of accidentally unlocking keys or pressing the bolus buttons. 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. Consequently, the manufacturer has received reports of unintended boluses being delivered.
All healthcare workers responsible for patients who use these devices and diabetes departments.
- Identify affected patients and pumps (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
This Medical Device Alert is to ensure that all relevant organisations are aware of this FSN and encourage their patients to apply the key frames.
Deadline for actions
Actions must be completed by the 2nd April, 2019
Remember: If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.