Freedom of Information request on issues with flash glucose sensors (FOI 21/795)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-july-2021/freedom-of-information-request-on-issues-with-flash-glucose-sensors-foi-21795
27th July 2021
FOI 21/795
Dear
Thank you for your email dated 10th July 2021, in which you questioned:
Please could you tell me if the number of reported issues has increased with flash glucose sensors in the last 3 months compared to the rate a year ago?
The total number of reports received by MHRA in the last 3 months (between the period of April to July 2021) and involving flash glucose sensors was 191 compared to 48 reports received in the same period a year ago (April to July 2020). Overall, 507 reports were received concerning these devices in the last year (July 2020 to July 2021).
The number of reports is accurate at the time they were taken from our database, and minor changes in the numbers can occur if the reporter of the incidents gives us more details later.
Please note that a report of an adverse incident does not mean the testing device caused the incident. Moreover, the information we hold on our database is not a full picture of all the device-related incidents that happened during this period, it is just a snapshot.
Therefore, our data should NOT be used to make a judgement on the safety of this type of devices (flash glucose sensors) or how likely it is to be involved in an adverse incident when using this type of device.
The reason for reporting can be just a suspicion that an incident was caused by a device or the way in which it was being used. Reports might be related to events which resulted in no injury, minor injury or a death or serious deterioration in health or the potential for these events. It is not compulsory for healthcare professionals and members of the public to report incidents directly to MHRA but we strongly encourage this.
MHRA continues to monitor the safety and performance of all medical devices and encourages patients to report any adverse incidents via the Yellow Card Scheme - MHRA.
The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information please visit:
If you have a query about the information provided, please reply to this email
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Information Commissioner’s Office
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Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre