Freedom of Information request on yellow card reports for any model of Insulin Pump where a death was determined to have been a result of a pump defect (FOI 22/763)
Published 21 December 2023
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FOI 22/763
21st July 2022
Dear
Thank you of your email dated 17th June 2022, where you requested:
“Number of reports received since 1st January 2017 via Yellow Card for any model of Insulin Pump where a death was determined to have been a result of a pump defect.”
The MHRA have received no reports via Yellow Card for any model of Insulin Pump where a death was determined to have been a result of a pump defect as of 01st January 2017 to 05th July 2022 inclusive.
We have received fourteen reports of fatal events during this period. This includes reports from manufacturers, healthcare professionals and members of the public. Of these fourteen reports, six cases were determined to have no device problem, five cases the root cause could not be established as the devices were not returned for investigation, one case was determined to have a root cause traced to the environment and two cases are pending the outcome of the investigation.
Please note, these numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
We hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division