Patients who use insulin pumps or continuous glucose monitors (CGMs) are being asked by the Medicines and Healthcare Products Regulatory Agency (MHRA) to promptly report any safety issues with their devices via the MHRA Yellow Card program.
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 utilizes 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. To aid this vital reporting, the MHRA has introduced new step-by-step guidance, giving individuals living with diabetes detailed information on how to report any safety concerns with their device and what information they need to include. This guidance provides examples of the types of issues which should be flagged and images to help guide users in their reporting.
Examples of the types of issue with continuous glucose monitors and insulin pumps that should be reported include:
- Concerns with accuracy of delivery from the insulin pump (for example, suspected underdose or overdose, unexpected bolus doses, non-delivery of insulin)
- Concerns with accuracy of results from a continuous glucose monitor (CGM). As part of your report, please tell us what the readings were on both the CGM and the approved blood glucose meter (see page 6)including the time elapsed between the 2 readings
- Skin reaction to the sensor adhesive. If a patch test was carried out, please let us know. Technology concerns, such as:
- Connectivity issues between the various parts of the diabetes management system
- Concerns with the touchscreen, display or buttons
- Physical failures, including leaks and cracks
