PFD report

Sybil Morgan-Gray · Prevention of Future Deaths report

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Issued 7 May 2025•Inner North London

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
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
4

Described in 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.

Report evidence summary

Concerns raised1

  1. Failure of blood gas machines to clearly indicate unrecordably low blood glucose levels
    Part of recurring concern: Failure to ensure clinical investigation results are reliably available, interpreted and acted uponPart of recurring concern: Failure to reliably measure and monitor blood glucose levels
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.3

  1. Action

    Share applicable report details with the manufacturer for review through its ongoing post-market surveillance.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 20 May 2025.
  2. Action

    Investigate whether interpretation of glucose and other out-of-range point-of-care analyser results presents a wider safety issue.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 20 May 2025.
  3. Action

    Work with the trust to resolve any identified training issues relating to interpretation of analyser results.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 20 May 2025.

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

Failure of blood gas machines to clearly indicate unrecordably low blood glucose levels

Wider context from the report

“1. A concern regarding the interpretation of blood gas machine readings. Specifically, when blood glucose levels are unrecordably low, the machines report this as ‘- - -’. This display can be misinterpreted as indicating the sample is unanalysable, rather than accurately reflecting an extremely low glucose level. This misinterpretation could lead to delayed or inappropriate clinical responses, potentially resulting in future deaths. It was unclear why the results are not recorded as ‘Low’ or similar. ”

Is this part of a recurring concern?

Yes — Failure to ensure clinical investigation results are reliably available, interpreted and acted upon; Failure to reliably measure and monitor blood glucose levels.

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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

Share applicable report details with the manufacturer for review through its ongoing post-market surveillance.

Verbatim wording from the response

“It is our intention to share applicable details of this report with the manufacturer so that they can review this case as part of their on-going post market surveillance activities, and to work with the trust to resolve any identified training issues that may have arisen. We will also engage with NHS England colleagues to determine if any additional similar cases have been reported to Learn from Patient Safety Events and if there are, will work with NHSE to ensure appropriate training is in place.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 3 · response
Published 20 May 2025

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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

Investigate whether interpretation of glucose and other out-of-range point-of-care analyser results presents a wider safety issue.

Verbatim wording from the response

“It is therefore important that device users are familiar with any warnings or symbols displayed on the device and the recommended course of action, particularly when results fall outside of the reporting range. We have investigated whether there is a wider issue across all point of care analysers and can confirm that we have not identified any further safety signals reported through our Yellow Card scheme associated with the interpretation of glucose results, or any other point of care results, outside the reporting range.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 3 · response
Published 20 May 2025

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

Work with the trust to resolve any identified training issues relating to interpretation of analyser results.

Verbatim wording from the response

“It is our intention to share applicable details of this report with the manufacturer so that they can review this case as part of their on-going post market surveillance activities, and to work with the trust to resolve any identified training issues that may have arisen. We will also engage with NHS England colleagues to determine if any additional similar cases have been reported to Learn from Patient Safety Events and if there are, will work with NHSE to ensure appropriate training is in place.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 3 · response
Published 20 May 2025

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.1

  1. 1

    Engage NHS England colleagues to determine whether similar cases have been reported through Learn from Patient Safety Events.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 20 May 2025.

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

Engage NHS England colleagues to determine whether similar cases have been reported through Learn from Patient Safety Events.

Verbatim wording from the response

“It is our intention to share applicable details of this report with the manufacturer so that they can review this case as part of their on-going post market surveillance activities, and to work with the trust to resolve any identified training issues that may have arisen. We will also engage with NHS England colleagues to determine if any additional similar cases have been reported to Learn from Patient Safety Events and if there are, will work with NHSE to ensure appropriate training is in place.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 3 · response
Published 20 May 2025

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

Official responses located
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Data last updated 7 September 2026