MHRA Alert – Insulin Pumps and CGM Equipment: Report Safety Concerns via Yellow Card

New Guidance for Diabetes Equipment Users

The MHRA has published updated guidance to help users of insulin pumps and continuous glucose monitoring (CGM) equipment report suspected adverse incidents and safety concerns through the Yellow Card scheme.

What You Need to Know

This guidance is aimed at:

• Users of insulin pumps and CGM devices
• Family members and carers
• Healthcare professionals supporting patients with diabetes

The Yellow Card scheme is the UK's pharmacovigilance system for reporting suspected safety issues with medicines and medical devices. By encouraging direct reporting from users and their representatives, the MHRA can identify emerging safety signals more quickly and take action to protect public health.

Why This Matters

Insulin pumps and CGM systems are critical for diabetes management. Any malfunction, connectivity issue, inaccuracy, or adverse event should be documented and reported to help maintain device safety and performance across the NHS and independent practice.

What to Report

Users and carers should report:

• Device malfunctions or unexpected behaviour
• Inaccurate readings or sensor failures
• Connectivity or software issues
• Any suspected adverse event or injury related to the device
• Concerns about device quality or durability

How to Report

Reports can be submitted directly to the MHRA Yellow Card scheme online, by phone, or via your healthcare provider. Full details and the reporting form are available on the MHRA website.

For Healthcare Professionals

We encourage all clinicians and controllers to share this guidance with patients, families, and carers using insulin pumps or CGM equipment. Supporting patient-led reporting strengthens pharmacovigilance and helps protect device users across the UK.

Read the full MHRA guidance: Insulin pumps and CGM equipment: Yellow Card reporting guidance