Image source: https://yellowcard.mhra.gov.uk
Faulty sensors, unexplained high glucose levels, insulin delivery problems and repeated device failures can all be reported directly to the MHRA.
Yet many people with diabetes are unaware that the UK's Yellow Card Scheme covers insulin pumps, CGMs and hybrid-closed loop technology as well as medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging more people with diabetes to report suspected safety concerns involving diabetes technology, saying reports from users can help identify problems, monitor trends and improve device safety.
As more people use CGMs, insulin pumps and hybrid-closed loop systems, reports from users are becoming an increasingly important source of real-world safety information.
Why your report could make a difference
Most safety alerts, investigations and recalls start with someone spotting a problem.
One faulty sensor, insulin pump issue or unexplained device failure might seem like an isolated incident. But when similar reports are submitted by multiple users, regulators can begin to identify patterns that may otherwise go unnoticed.
In some cases, reports contribute to wider investigations, safety notices or product recalls.
That is why the MHRA says it wants to hear from people using diabetes technology, even if they are not completely certain what caused the problem.
You do not need proof that a device was at fault before submitting a report.
What is the Yellow Card Scheme?
The Yellow Card Scheme is the UK's official system for reporting safety concerns involving medicines, vaccines and medical devices.
While many people associate Yellow Card reports with medication side effects, the scheme is also used to collect reports about insulin pumps, CGMs and other diabetes technology.
The MHRA uses reports to investigate potential issues, identify trends and determine whether further action may be needed.
The system is open to patients, parents, carers and healthcare professionals.
Why is the MHRA focusing on diabetes technology?
The number of people using diabetes technology has grown rapidly in recent years.
CGMs are now widely used across the NHS, while access to hybrid-closed loop systems continues to expand throughout the UK.
Despite this growth, the MHRA says reports involving insulin pumps and CGMs appear lower than expected compared with the number of people using them.
The regulator believes some issues may go unreported because many users do not realise device problems can be reported through the Yellow Card Scheme.
Others may assume that reporting an issue to the manufacturer is enough.
Both are important.
Manufacturers investigate individual product issues, while Yellow Card reports help regulators monitor broader safety concerns across devices and brands.
What kinds of problems can be reported?
The MHRA encourages people with diabetes to report any suspected safety concern involving diabetes technology.
Examples include:
- insulin pumps not delivering insulin as expected
- suspected under-delivery or over-delivery of insulin
- unexplained insulin leakage
- pump alarms failing to activate
- repeated unexplained high glucose levels linked to a device issue
- inaccurate CGM readings
- repeated signal loss or Bluetooth connection failures
- sensor failures or early sensor loss
- software problems
- touchscreen or display faults
- adhesive-related skin reactions
- cracks, leaks or physical device damage
Reports do not need to involve serious harm.
Even issues that seem minor may help identify patterns affecting larger numbers of users.
What information should you include?
The more information included in a report, the easier it is for investigators to understand what happened.
Useful details can include the manufacturer, device model, lot or serial number, when the issue occurred and what happened afterwards.
For CGMs, screenshots, glucose readings and comparisons with finger-prick blood glucose results may also help.
For insulin pumps, details about insulin delivery, correction doses, ketones and any troubleshooting steps can be useful.
If the issue led to severe hypoglycaemia, ketones, DKA, hospital attendance or medical treatment, that information should also be included.
How do you submit a report?
Reports can be submitted online through the MHRA Yellow Card website.
The reporting process guides users through the information needed and can be completed by patients, parents, carers or healthcare professionals.
The MHRA has also published dedicated guidance for insulin pump and CGM users explaining what information to include and how reports are assessed.
Submitting a report does not usually take long, but the information provided can contribute to a wider understanding of device safety.
Reporting does not replace medical advice
The Yellow Card Scheme is designed to collect safety information, not provide medical support.
Anyone experiencing persistent high glucose levels, ketones, severe hypoglycaemia or symptoms of DKA should seek medical advice immediately.
Reporting a concern can still be valuable, however, even if the issue has already been resolved.
The MHRA says reports from users play an important role in helping identify emerging safety concerns and improve understanding of how devices perform in real-world use.
As diabetes technology becomes more widely used, those reports may help identify problems earlier and contribute to improvements that benefit the wider diabetes community.
Key points
- Problems with CGMs, insulin pumps and hybrid-closed loop systems can be reported directly to the MHRA.
- You do not need proof that a device caused the issue before making a report.
- Reports help regulators identify potential safety concerns and monitor trends.
- Patients, parents, carers and healthcare professionals can all submit reports.
- Device problems can include insulin delivery issues, sensor failures, inaccurate readings and software faults.
- Serious symptoms such as ketones, DKA or severe hypoglycaemia still require urgent medical attention.
What happens next?
The MHRA wants more people with diabetes to be aware that device problems can be reported directly through the Yellow Card Scheme.
As use of CGMs, insulin pumps and hybrid-closed loop systems continues to grow, reports from users are likely to become increasingly important in identifying emerging safety concerns.
For people with diabetes, the message is simple: if something does not seem right with a device, do not assume someone else will report it.
Your report could help identify a wider issue affecting other users.
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