Experiencing diabetes medtech issues? How to report it using the Yellow Card Scheme

MHRA launch initiative to report issues with CGMs and insulin pumps to the Yellow Card scheme.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched an initiative encouraging people to report any issues with CGMs and insulin pumps to the Yellow Card scheme. The initiative is designed to help the MHRA track and address any safety concerns that may arise.

Why report to the yellow card scheme?

With over 5.6 million people in the UK managing diabetes, technology such as insulin pumps and CGMs plays a critical role in improving daily life by offering more precise blood sugar management. However, like any technology, these devices can sometimes encounter issues. When something doesn’t work as intended, it may affect insulin delivery or glucose readings—potentially leading to unintended health consequences. Reporting even minor device issues can help keep you and others safe.

How to use the yellow card scheme

To make the process simple, the MHRA has created a step-by-step guide for submitting reports. If you’re experiencing issues, here are some examples of situations that should be reported:

• Insulin pump concerns: Issues such as inaccurate dosing (either underdosing or overdosing), unexpected insulin delivery, or complete non-delivery.
• CGM inaccuracies: If your CGM provides inconsistent readings, this could impact how you manage your insulin.
• Connectivity issues: Problems with connected technology, such as between your insulin pump and CGM, which can disrupt effective monitoring and dosing.
• Device interface issues: Unresponsive or malfunctioning touchscreens, buttons, or displays.
• Physical defects: Leaks, cracks, or other physical failures in the device.

If you notice any of these issues, follow the guidance to complete a Yellow Card report. You can submit your report easily online through the Yellow Card website or via the free Yellow Card app.

What to do after reporting

While it’s crucial to report device issues, remember to also contact your healthcare team. They can provide advice on managing any immediate concerns and help ensure your diabetes care stays on track.

Professor Partha Kar, the NHS England Type 1 Diabetes & Technology Lead welcomed the reporting scheme:

“This initiative will help to ensure standards stay at the highest level as the market continues to expand with new developers,”