FOI release

Adverse incident reports for insulin pump devices, Northern Ireland

Case reference FOI2026/00816

Received 24 July 2026

Published 8 September 2026

Request

Under the Freedom of Information Act 2000, I am requesting the following information held by the MHRA. 1. The number of adverse incident reports received by the MHRA relating to continuous subcutaneous insulin infusion (CSII) pumps or automated insulin delivery (AID) / hybrid closed loop systems, where the reporting organisation or patient location was in Northern Ireland, for the period 1 January 2019 to the date of this request, broken down by year and by outcome severity (death, serious harm, other). 2. Where the outcome was recorded as death, whether the report identifies the suspected cause as device malfunction, software/algorithm fault, or user error, where this classification is recorded. 3. Whether any of these reports relate to devices also the subject of a Field Safety Notice or recall during the same period, and if so, please identify which notice(s).

Response

See attached

Documents

• FOI 2026 00816 Tables 1 and 2.pdf (81.0 KB)
• FOI2026 00816 (redacted).pdf (1.1 MB)

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