Doctor issues urgent 'report now' warning to those with condition that affects millions

Dr. Alison Cave, a product regulator at the Medicines and Healthcare Products Regulatory Agency, has stressed that prioritising patient safety is their main concern.

A warning has been issued to millions of people due to growing concerns that too few individuals are reporting problems with a crucial medical device - potentially putting patients at risk.

In the UK alone, over 5.6 million individuals live with diabetes, and a significant number of them rely on insulin pumps or continuous glucose monitors (CGMs) to manage their condition effectively.

Experts at the Medicines and Healthcare Products Regulatory Agency (MHPRA) state that although these devices are generally dependable and can enhance patient's quality of life, issues can still arise. These specialists believe that not all problems experienced by users are being reported.

They said: "Adverse incidents relating to these devices can occur, and while most of these incidents do not result in harm to the patient, they can potentially lead to the incorrect amount of insulin which can lead to abnormal blood sugar levels, with potentially serious health consequences."

The "Yellow Card" reporting scheme enables individuals experiencing issues to inform the experts about what has gone wrong, reports the Gloucestershire Live.

However, the MHRA has indicated that as of January 2023, it received less than 300 Yellow Card reports concerning these devices, from both the public and healthcare professions. This sum is a lot lower than anticipated.

They are now reminding everyone that it's crucial to reach out if they have any safety concerns.

Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority, which is why we urge anyone using devices to manage their diabetes to report to us without delay any safety concerns they may have. We know adverse incidents can occur with the use of these devices. The vast majority of these incidents don’t result in harm but potentially could have serious consequences.

"Every report is valuable to us as it will provide valuable insight and potentially inform future regulatory measures designed to protect patients. We are ready to take whatever action is needed.

"If you are concerned that there is an issue with any of your diabetes devices, please use the guidance to complete a Yellow Card report online using the Yellow Card website or via the free Yellow Card app."

Douglas Twenefour, Head of Care at Diabetes UK, said: "Diabetes technology can be a life-changing tool, helping people living with the condition improve their quality of life.

"Unfortunately, we know that sometimes this technology doesn’t work as intended, so it is important that users of diabetes tech have a clear and accessible way to report any issues with continuous glucose monitors, insulin pumps and pens.

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"Diabetes UK welcomes any guidance that gives reassurance for people using diabetes tech to highlight potential problems quickly and easily. We would encourage anyone with a concern about diabetes tech to report it, as this vital information can help improve the quality of devices.

"However, if there is any immediate concern about technology that could affect a person’s safety, advice from an appropriate healthcare professional should be sought first."

Professor Partha Kar, NHS England Type 1 Diabetes & Technology lead, said: "We welcome this work and it's important role in ensuring safety while we oversee the widespread adoption of diabetes technologies using continuous glucose monitors and insulin pumps.

"These devices can be life-changing for people living with diabetes, giving them the confidence to go about their days knowing they are safe and able to enjoy themselves, so their operationally effectiveness is of paramount importance."

The MHRA also encourages individuals to consult a healthcare professional promptly if they suspect their health has been affected by a potential safety issue related to their device.

Examples of issues 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).
• Skin reaction to the sensor adhesive.
• Technology concerns, such as connectivity issues between the various parts of the diabetes management system, concerns with the touchscreen, display or buttons
• Physical failures, including leaks and cracks

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