MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference: (b)(4).According to the complaint the customer experienced inaccurate thb (hemoglobin) results with their abl90 flex blood gas analyzer (serial no; (b)(6) on (b)(6) 2025.The customer describes that the medical staff used the analyzer for testing patients' blood gas, blood oxygen, electrolytes, and metabolites.Under normal operating conditions, the measured hemoglobin concentration was only 6.5 g/dl.If this value were accurate, it would indicate massive bleeding requiring emergency treatment.However, the patient exhibited no such symptoms.This necessitated a repeated complete blood count, which showed a hemoglobin concentration of 11.1 g/dl, within the normal range.This adverse event increased the patient's needle-stick pain and resulted in additional medical expenses.
Event or Problem Description
Radiometer reference: (b)(4) according to the complaint the customer experienced inaccurate thb (hemoglobin) results with their abl90 flex blood gas analyzer (serial no; (b)(6)) on (b)(6) 2025.The customer describes that the medical staff used the analyzer for testing patients' blood gas, blood oxygen, electrolytes, and metabolites.Under normal operating conditions, the measured hemoglobin concentration was only 6.5 g/dl.If this value were accurate, it would indicate massive bleeding requiring emergency treatment.However, the patient exhibited no such symptoms.This necessitated a repeated complete blood count, which showed a hemoglobin concentration of 11.1 g/dl, within the normal range.This adverse event increased the patient's needle-stick pain and resulted in additional medical expenses.Information received from the customer 25jan2026: "when analyzing the measurement result that was reported as "abnormal" by the analyzer, error code 0581 was present at the same time.After inspection by the engineer, no instrument malfunction was identified.In addition, according to the customer, all measurement results before and after this "abnormal" result were normal.Therefore, the engineer concluded that the issue was most likely related to the sample.However, at the customer site, it was not possible to identify the specific operator involved at the time, and thus it could not be confirmed whether any pre[?]analytical error occurred.Due to high staff turnover at the customer site, some newly joined personnel have not received training from radiometer and were only trained internally by the department.Because the operator at the time could not be identified, it cannot be confirmed whether the operator was properly trained in using the device".

• Brand Name: ABL90 FLEX ANALYZER
• Common Device Name: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 24143801
• Report Number: 3002807968-2026-00009
• Device Sequence Number: 15668438
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1164N001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female