Insulin pumps and continuous glucose monitoring (CGM) equipment: guidance for users on reporting suspected adverse incidents and safety concerns to the MHRA’s Yellow Card scheme

· seek medical advice without delay if you have concerns that your health has been impacted by a potential safety issue relating to your device

· use an alternative device if you suspect your current device is not performing adequately in managing your diabetes. Ensure you have an alternative device available at all times

· it is important to read the guidance being given to you on how to report concerns with the equipment used to manage your diabetes

· it is important that you report safety concerns with your devices to the Yellow Card scheme. Yellow Card reports help the MHRA to identify safety issues and to consider actions to improve the safety and performance of devices used by people living with diabetes

· if you believe there is a safety problem with your equipment, submit a report via the Yellow Card scheme and use the guidance document to help you create a report.

 

Further information is available at: https://www.gov.uk/government/publications/report-safety-concerns-with-insulin-pumps-and-continuous-glucose-monitoring-equipment