Are you experiencing issues with your Diabetes MedTech?
People living with diabetes who use an insulin pump or continuous glucose monitor have been asked to report any safety problems with their device without delay to the Yellow Card scheme.
The Yellow Card reporting scheme has been set up by the Medicines and Healthcare products Regulatory Agency (MHRA) so the MHRA can identify safety concerns that might require action.
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 Guidance provided by MHRA.