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James Hedge

Ref: 2016-wp25334 Date: 27 Jul 2016 Coroner: Andrew Barkley Area: South Wales Central Responses identified: 4 / 4 View PDF

Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.

Date 27 Jul 2016
56-day deadline 15 Sep 2016
Responses identified 4 of 4
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.
View full coroner's concerns
(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.

(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.

Responses

4 respondents
Medicine and Healthcare Products Regulatory Agency Other
PDF
Action Taken

The MHRA reports that the pump manufacturer updated handling instructions, user manuals, and issued a Field Safety Notice. The MHRA also published a Medical Device Alert and a press release to reinforce safety messages, and raised awareness at a National Medical Device Safety Officers' Webex. (AI summary)

Welsh Government Devolved Administration
PDF
Noted

The Welsh Government acknowledges the coroner's concerns, noting actions taken by the MHRA and the pump manufacturer to update guidance. They highlighted their existing National Diabetes Delivery Plan and ongoing work by the Diabetes Implementation Group to ensure safety standards and education, and that this plan is being refreshed. (AI summary)

NHS England NHS / Health Body
PDF
Action Planned

NHS England is reviewing how to support greater take-up and consistency of structured education, which will consider key content related to insulin pump risks and hyperglycaemia management. They also note the MHRA's recent Medical Device Alert regarding specific insulin pumps and advise on its distribution to healthcare workers. (AI summary)

Roche Diabetes Care Limited
PDF
Action Taken

Roche Diabetes Care Limited issued a Field Safety Notice to reinforce existing instructions for correct insulin cartridge insertion in Accu-Chek Insight insulin pumps, which will be added to user manuals from October 2016. They state they provide extensive product information and training, and keep these methods under constant review. (AI summary)

Report sections

Investigation and inquest
On 27th January 2016 I commenced an investigation into the death of James Michael HEDGE aged 18. The investigation concluded at the end of the inquest on 6th July 2016. The conclusion of the inquest was that of a narrative conclusion and the medical cause of death was 1a.Diabetic Ketoacidosis.

The narrative conclusion was “James Michael HEDGE died from the effects of diabetic ketoacidosis in circumstances in which he had high blood sugar levels and there was a leakage in the insulin pump he was using. The most likely cause of that was the incorrect usage of the machine.
Circumstances of the death
James Michael HEDGE was a type 1 insulin dependent diabetic and had been from the age of three. After concern for his welfare, his room at Cardiff University was entered and he was discovered deceased on his bed. It was noted by one of the attending officers that an insulin pump, which was connected to him, was “beeping” A subsequent investigation of the pump revealed that the insulin cartridge had been fitted incorrectly and had leaked.

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Report details

Reference
2016-wp25334
Date of report
27 July 2016
Coroner
Andrew Barkley
Coroner area
South Wales Central

Responses identified

Responses identified 4 of 4
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 15 Sep 2016.

Sent to

Medicines and Healthcare Products Regulatory Agency
NHS England
NHS Wales
Roche Diagnostics Limited

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.