FDA Adverse Event Other Summary report: N

BLOOD GAS ANALYZER

MDR report key: 25047432 · Received April 30, 2026

Report

Report Number
MW5187522
Event Type
Other
Date Received
April 30, 2026
Report Date
April 28, 2026
Manufacturer
UNKNOWN
Product Code
CHL
Report Source
Voluntary report
Reporter Location
UK
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ARTERIAL BLOOD GAS (ABG) ANALYSERS HAVE AN INTERNAL ALGORITHM THAT ADJUSTS THE OUTPUT FOR THE PATIENT'S TEMPERATURE. FOR THIS TO WORK, THE ABG OPERATOR NEEDS TO ENTER THE PATIENT'S TEMPERATURE. THIS ABG PAPER SHOWS THAT MOST OPERATORS (84%) DO NOT ENTER THE PATIENT'S TEMPERATURE IN COVID PATIENTS WITH HIGH TEMPERATURES. THIS RESULTS IN SUBSTANTIAL CHANGES TO THE ABG ANALYSER OUTPUTS. THE CONSEQUENCE IS THAT APPROXIMATELY 30% OF PATIENTS WITH HIGH TEMPERATURES WHO IN REALITY HAVE BLOOD ACIDOSIS (USING THE TEMPERATURE ADJUSTED PH) DO NOT APPEAR TO HAVE ACIDOSIS (AS THE TEMPERATURE ADJUSTED PH IS NOT GENERATED AS THE HIGH TEMPERATURE IS NOT ENTERED INTO THE ABG ANALYSER). HENCE, THEY WILL NOT RECEIVE ESCALATION FOR THE CAUSE OF THEIR ACIDOSIS (RESPIRATORY FAILURE, SEPSIS ETC). I HAVE WORKED IN MEDICINE FOR OVER 30 YEARS, AND I THINK THE ROOT CAUSE IS THAT THE PERSON OPERATING THE ABG MACHINE IS OFTEN A NURSE OR SUPPORT WORKER WHO IS NOT FAMILIAR WITH THE PATIENT AND THE NEED FOR ACCURATE TEMPERATURE INPUT. WE WERE SURPRISED BY HOW BIG THE EFFECT SIZE WAS OF OMITTING THE ABG ANALYSER ALGORITHM IN PATIENTS WITH HIGH TEMPERATURES. I SUSPECT THIS IS A GLOBAL PROBLEM. AN ALERT TO ENHANCE AWARENESS OF THIS SYSTEMIC ERROR WOULD HELP IMPROVE THE CLINICAL CARE OF PATIENTS WITH SEPSIS, RESPIRATORY FAILURE AND OTHER CAUSES OF ACIDOSIS. THE PAPER IS PUBLISHED HERE HTTPS://EMJ.BMJ.COM/CONTENT/EARLY/2026/04/27/EMERMED-2025-215822.FULL . IF YOU EMAIL ME I CAN SEND YOU A COPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
620266 BLOOD GAS ANALYZER ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other