Over 5.6 million people in the UK live with diabetes, and many of them rely on devices to manage their condition and quality of life.
However, adverse incidents related to these devices are not unheard of, and while they largely do no harm to the patient they could potentially deliver incorrect insulin dosage, leading to abnormal blood sugar levels and serious health consequences, says the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA has a yellow card reporting scheme to identify safety concerns that may require action.
As of January 2023, the MHRA received 300 yellow card reports related to these devices from healthcare professionals and the public, which is significantly fewer than expected, given their widespread use.
The MHRA is, therefore, reminding users to report adverse incidents and potential safety issues.
It has introduced a new guidance for reporting safety concerns with devices, specifying the information to be included.
Dr Alison Cave, MHRA Chief Safety Officer, says adverse incidents can occur with the use of the devices.
“The vast majority of these incidents don’t result in harm, but potentially could have serious consequences,” she says.
Examples of issues to be reported with continuous glucose monitors (CGM) and insulin pumps include concerns over accuracy of delivery from the insulin pump (suspected underdose or overdose, non-delivery of insulin); skin reaction to the sensor adhesive — if a patch test was done; technology concerns such as connectivity issues in the diabetes management system, and usage issues in touchscreen, display, or buttons; and physical failures including leaks and cracks.
(Source: UK MHRA)