Freedom of Information request on the yellow card reports following the Omnipod DASH System produced by Insulet (FOI 22/369)
Published 31 May 2022
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FOI 22/369
16th February 2022
Dear
Thank you for your information request, dated 25th January 2022, where you asked for the following information:
I would be grateful if you would provide a list of and redacted details of all adverse incident/yellow card reports received relative to the Omnipod DASH System produced by Insulet.
Please also provide a list and redacted details of all adverse incident/yellow card reports relative to any “over” or “unprogrammed” delivery of insulin by any insulin pump system produced by Insulet.
Unfortunately, the information is exempt from release under section 44:
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
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constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
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relates to the affairs of Insulet Corporation, a business which continues to exist.
On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
I would like to take this opportunity to reassure you that the MHRA keeps the safety of all medical devices under close and continual review. Should any important safety issues be identified, appropriate regulatory action will be taken.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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Wycliffe House
Water Lane
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Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre