Source · Prevention of Future Deaths

James Hedge

Ref: 2016-wp25334 Date: 27 Jul 2016 Coroner: Andrew Barkley Area: South Wales Central 4 responses identified · 4 indexed addressees View PDF

AI-generated concerns summaryThe coroner notes that advice and guidance for insulin pumps do not adequately highlight dangers of misuse, and diabetic patient education lacks focus on the rapid life-threatening nature of unmanaged hyperglycaemia.

Date 27 Jul 2016

56-day deadline 15 Sep 2016 stated in the report

Responses identified 4 of 4

Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary

The coroner notes that advice and guidance for insulin pumps do not adequately highlight dangers of misuse, and diabetic patient education lacks focus on the rapid life-threatening nature of unmanaged 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

Welsh Government

Devolved Administration

Letter dated 16 Sep 2016 PDF

AI-classified response stance Noted

AI-generated response summary

• The Welsh Government noted that the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Medical Device Alert concerning incorrect cartridge insertion and under-delivery of insulin. • The Welsh Government noted that the manufacturer issued an urgent field safety notice to all insulin pump teams and users, and stated that handling instructions would be updated. • The Diabetes Implementation Group identified insulin pump provision as a national priority, with activity aimed at health boards ensuring safety standards comply with NICE guidelines, including annual education updates.

NHS England

NHS / Health Body

PDF

AI-classified response stance Action Planned

AI-generated response summary

• NHS England will consider issues related to the risks from incorrect use of insulin pumps and the management of hyperglycaemia as part of a review into supporting structured education.

Medicine and Healthcare Products Regulatory Agency

Regulator / Inspectorate

Letter dated 13 Sep 2016 PDF

AI-classified response stance Action Taken

AI-generated response summary

• The Medicine and Healthcare Products Regulatory Agency (MHRA) published a Medical Device Alert (MDA) on 15 August 2016 to inform healthcare providers of new instructions for changing insulin cartridges and the importance of communicating risks, and also issued a press release. • The MHRA raised awareness of the MDA and the manufacturer's Field Safety Notice during a National Medical Device Safety Officers’ Webex on 7 September 2016. • The MHRA will monitor the manufacturer's progress with reviewing technical enhancements to the system and will continue to monitor the Field Safety Corrective Action and investigate any further incidents received.

Roche Diabetes Care Limited

Letter dated 14 Sep 2016 PDF

AI-classified response stance Action Taken

AI-generated response summary

• Roche Diabetes Care Limited issued a Field Safety Notice in May 2016 to reinforce existing advice on correct insulin pump cartridge insertion and emphasize related risks. • The company updated pump training sessions with immediate effect, focusing on reinforced instructions for correct cartridge insertion. • Roche Diabetes Care Limited stated that the reinforced instructions from the Field Safety Notice would be incorporated into the Accu-Chek Insight insulin pump product manual from October 2016.

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.

Similar PFD reports

Shared signals

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 (stated in the report).

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.

Contains public sector information licensed under the Open Government Licence v3.0.