PFD report

James Michael HEDGE · Prevention of Future Deaths report

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Issued 27 Jul 2016•South Wales Central

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
4

Named on the report

Responses found
4

Of 4 recipients

Stated actions
13

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Inadequate education on managing hyperglycaemia and its life-threatening progression
  2. Inadequate advice and guidance on insulin pump misuse dangers
    Part of recurring concern: Failure to ensure clear and followed instructions for safe equipment use
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.10

  1. Action

    Review user manuals and training materials in response to the inquest evidence and identified safety concerns.

    Stated by Recipient name withheldStated completedThe respondent said that this action was complete when they made their response on 27 July 2016.
  2. Action

    Update pump training sessions using the new Training Handling chart to reinforce correct insulin-cartridge insertion instructions.

    Stated by Recipient name withheldStated in progressThe respondent said that this action was in progress when they made their response on 27 July 2016.
  3. Action

    Incorporate the Field Safety Notice’s reinforced cartridge-insertion instructions into the product manual supplied with new pumps.

    Stated by Recipient name withheldStated plannedThe respondent said that this action was planned when they made their response on 27 July 2016.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    Individual diabetes education and clinical guidance should be directed by the patient's treating healthcare professionals.

    Stated by Recipient name withheldRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do 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. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do 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. ”

Is this part of a recurring concern?

Yes — Failure to ensure clear and followed instructions for safe equipment use.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review user manuals and training materials in response to the inquest evidence and identified safety concerns.

Verbatim wording from the response

“As a preliminary matter, please be aware that patient safety is our utmost priority. We have therefore carefully reviewed our user manuals and training materials in response to the evidence given at the inquest as well as to your matters of concern. In this response we focus on the Accu-Chek Insight insulin pump system, the pump used by Mr Hedge. However similar information and training is provided in relation to other Roche insulin pumps”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 1 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Update pump training sessions using the new Training Handling chart to reinforce correct insulin-cartridge insertion instructions.

Verbatim wording from the response

“As part of our Field Safety Notice we initiated updates to the pump training sessions with immediate effect. This focused on the use of the new Training Handling chart (see Annex B) as part of the reinforced instructions for correct insertion of the insulin cartridge.”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 5 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Incorporate the Field Safety Notice’s reinforced cartridge-insertion instructions into the product manual supplied with new pumps.

Verbatim wording from the response

“From October 2016, the reinforced information set out in the FSN will be incorporated in the Accu-Chek Insight insulin pump product manual”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 4 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Issue and distribute a Field Safety Notice reinforcing correct insulin-cartridge insertion instructions and associated misuse risks.

Verbatim wording from the response

“Chek Insight. The only addition to these materials is the Field Safety Notice which reinforced instructions for insertion of the cartridge - this was supplied to all Accu-Chek Insight pump users who are registered with Roche and to relevant Healthcare Professionals in May 2016.”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 3 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review how to support greater uptake and consistency of structured education, including content on incorrect pump use and hyperglycaemia management.

Verbatim wording from the response

“NHS England is currently reviewing how greater take-up and consistency of structured education can be supported and the issues of key content in relation to the risks from incorrect use of insulin pumps and the management of hyperglycaemia will be considered as part of this.”

Source location

2016-0269-Response-by-NHS-England
Page 1 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Ensure health boards’ insulin pump services meet NICE safety standards, including annual education updates.

Verbatim wording from the response

“The National Diabetes Delivery Plan for Wales recognises the importance of insulin pump provision and structured diabetes education (SDE). With regard to insulin pumps, the plan commits health boards to the provision of an insulin pump service in line with National Institute for Health and Care Excellence (NICE) guidance. As a result, our Diabetes Implementation Group has identified insulin pump provision as one of its national priority areas and has a specific line of activity aimed at health boards ensuring standards of safety comply with NICE guidelines including annual education updates.”

Source location

2016-0269-Response-by-Welsh-Government
Page 2 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Refresh and extend the National Diabetes Delivery Plan through 2020, retaining insulin pump provision and structured diabetes education as priority areas.

Verbatim wording from the response

“The national plan is currently being refreshed and extended to 2020; insulin pump provision and SDE will remain key areas of priority in the revised plan which will be monitored by the Diabetes Implementation Group.”

Source location

2016-0269-Response-by-Welsh-Government
Page 2 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Monitor insulin pump provision and structured diabetes education as priority areas through the Diabetes Implementation Group.

Verbatim wording from the response

“The national plan is currently being refreshed and extended to 2020; insulin pump provision and SDE will remain key areas of priority in the revised plan which will be monitored by the Diabetes Implementation Group.”

Source location

2016-0269-Response-by-Welsh-Government
Page 2 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct a further risk assessment of the insulin pump safety message.

Verbatim wording from the response

“In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 27 July 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Disseminate reinforced cartridge-changing instructions through a Medical Device Alert, press release and National Medical Device Safety Officers’ Webex.

Verbatim wording from the response

“In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 27 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Individual diabetes education and clinical guidance should be directed by the patient's treating healthcare professionals.

Verbatim wording from the response

“Roche Diabetes Care considers that information relating to hyperglycemia, diabetic ketoacidosis and associated clinical conditions should form part of the fundamental clinical training that all insulin patients should receive from their healthcare professional. Such advice is an important component of basic diabetes education and must have been provided to all insulin patients as a precondition for the use of our pump (see Accu-Chek Insight insulin pump user guide / preface). The patient information leaflet accompanying the insulin cartridge also includes similar information provided by the manufacturer of the insulin. By way of example, Novo Nordisk advises users of NovoRapid PumpCart:”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 4 · response
Published 27 July 2016

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing information and training adequately explain insulin-pump misuse risks, hyperglycaemia management and cartridge insertion consequences.

Verbatim wording from the response

“We believe this information is clear and comprehensive, to the extent that general clinical information may properly be supplied to patients by a pump manufacturer.”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 4 · response
Published 27 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The manufacturer cannot appropriately provide clinical information tailored to individual patients' medical conditions and circumstances.

Verbatim wording from the response

“The clinical information provided to patients by Roche Diabetes Care (and by other companies) in relation to the effects and management of diabetes, including the proper response to hyperglycemia and the risks associated with a high blood glucose, is therefore intended to supplement and reinforce the information provided to the individual patient by healthcare professionals, but not to act as a substitute for such information. Roche is not in a position to provide information on clinical matters tailored to the medical condition and personal circumstances of particular patients and it would not be appropriate for us to seek to do so.”

Source location

2016-0269-Response-by-Roche-Diabetes-Care-Limited
Page 4 · response
Published 27 July 2016

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Training healthcare professionals and patients is outside the respondent’s remit; manufacturers and healthcare providers have related instructional and training responsibilities.

Verbatim wording from the response

“In order to fulfil the requirements of the Medical Devices Directive and place a medical device on the market, the manufacturer must provide sufficient information and instructions to enable users of the device to operate it in accordance with its intended function. This should include any warnings and precautions to take and any undesirable side effects. The manufacturer should take into consideration the training and capacity of the intended user and, where appropriate, instructions should be provided in symbol form.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 27 July 2016

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. 1

    Continue monitoring Roche’s Field Safety Corrective Action and its long-term preventative action plan.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 27 July 2016.
  2. 2

    Conduct periodic signal detection reviews of incident reports for medical-device categories.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 27 July 2016.
  3. 3

    Investigate further incidents involving medical devices received by MHRA.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 27 July 2016.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    No systemic inadequacy in instructions or labelling has been identified for other manufacturers of insulin delivery systems.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue monitoring Roche’s Field Safety Corrective Action and its long-term preventative action plan.

Verbatim wording from the response

“The MHRA investigation has not yet been concluded. Roche Diabetes Care has indicated that they are reviewing technical enhancements to the design of the system. MHRA will monitor the progress of the manufacturer's long term preventative action plan.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 27 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct periodic signal detection reviews of incident reports for medical-device categories.

Verbatim wording from the response

“MHRA will continue to monitor the progress of the Roche Field Safety Corrective Action and will investigate any further incidents that we receive. We conduct signal detection activities where incident reports received for any given category of medical device are periodically reviewed.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 27 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Investigate further incidents involving medical devices received by MHRA.

Verbatim wording from the response

“MHRA will continue to monitor the progress of the Roche Field Safety Corrective Action and will investigate any further incidents that we receive. We conduct signal detection activities where incident reports received for any given category of medical device are periodically reviewed.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 27 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

No systemic inadequacy in instructions or labelling has been identified for other manufacturers of insulin delivery systems.

Verbatim wording from the response

“MHRA has not identified a systemic problem relating to the inadequacy of instructions for use and product labelling from other manufacturers of insulin delivery systems.”

Source location

2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 27 July 2016

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026