MHRA asks patients to report without delay any safety problem with their continuous glucose monitor or insulin pump
HM Government | Press Releases | Medicines and Healthcare products Regulatory Agency | 8 October 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report any safety problem with their device through the MHRA Yellow Card scheme without delay.
Over 5.6 million people in the UK live with diabetes, many of whom rely on these devices to manage their condition, and their use can significantly improve the quality of life for patients. However, adverse incidents relating to these devices can occur, and while most of these incidents do not result in harm to the patient, they can potentially lead to the incorrect amount of insulin which can lead to abnormal blood sugar levels, with potentially serious health consequences.
The MHRA utilises the Yellow Card reporting scheme for signal detection and trending activities to identify safety concerns that may require action. As of January 2023, the MHRA has received fewer than 300 Yellow Card reports from healthcare professionals and members of the public relating to these devices, which is significantly fewer than we would expect given their widespread use. The MHRA is therefore reminding users how to report adverse incidents and potential safety issues to us.