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.
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 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 or concerns with the touchscreen, display or buttons.
- Physical failures, including leaks and cracks.
For guidance to help you make the report, see the Yellow Card Scheme poster.