Freedom of Information request on the number of reported issues has increased with flash glucose sensors in the last 3 months compared to the rate a year ago (FOI 21/1227)
Published 31 May 2022
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FOI 21/1227
13th December 2021
Dear,
Thank you for your email dated 15th November 2021, in which you raised the question:
- 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?
I am pleased to provide you the following information.
The total number of reports received by MHRA in the last 3 months (between the period of August to November 2021) and involving flash glucose sensors was 240 compared to 82 reports received in the same period a year ago (August to November 2020). Overall, 720 reports were received concerning these devices in the last year (November 2020 to November 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 https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information
If you have any questions please reply to this email.
Kind regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000