Roche Diagnostics LimitedIncludes reports addressed to a minister or senior office-holder acting for this organisation.

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First report 27 Jul 2016•Latest report 27 Jul 2016

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

* 2026 is projected from reports observed to 7 Sep 2026.

Reports
1

Naming this recipient

Published responses
0%

Found for named reports

Concerns addressed
0

Across all linked responses

Stated actions
0

Described in responses

Concerns and recipient responses

Statements from Roche Diagnostics Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. Addressed to: Mr Roland DIGGELMANN, Chief Executive, Roche Diagnostics Limited.

    South Wales Central

    AI-generated summary

    James Michael HEDGE · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    James Michael HEDGE, an 18-year-old type 1 insulin-dependent diabetic, was found deceased in his room at Cardiff University with an insulin pump connected to him. The pump’s insulin cartridge had been fitted incorrectly and leaked, and the inquest recorded diabetic ketoacidosis as the medical cause of death. Concerns included inadequate guidance about the dangers of insulin-pump misuse and insufficient education about the potentially rapid, life-threatening consequences of hyperglycaemia.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Roche Diagnostics Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Inadequate education on managing hyperglycaemia and its life-threatening progression

    Wider context from the report

    “(2) The evidence showed that the education of diabetic patients does not adequately focus upon the potential consequences of failing to properly manage a hyperglycaemic state and in particular, how quickly such a state can become life threatening. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Roche Diagnostics Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Inadequate advice and guidance on insulin pump misuse dangers

    Wider context from the report

    “(1) The evidence showed that the advice and guidance in relation to the use of the insulin pump, which is one of several on the market, does not adequately highlight the dangers of misuse and the potential consequences which may follow if the device is not used correctly – in this case, the incorrect insertion of the insulin cartridge leading to a leak and loss of insulin at a time when blood sugars were high. ”
    Open source report
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026