MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the hospital reported, the patient was admitted for treatment.At 06:17 on (b)(6) 2025, a blood gas analysis was performed on an abl90 flex analyzer (serial no; (b)(6) as per medical orders, and the results showed sodium (na): 246 mmol/l.However, the biochemical blood test results from the laboratory indicated a sodium level of 143 mmol/l, revealing a significant discrepancy that severely impacted the diagnosis and treatment of the patient.After restarting the analyzer, a repeat test was conducted, showing sodium: 142 mmol/l.It is suspected that the device experienced an unexplained, sporadic system malfunction.The incident was immediately reported to the equipment department for inspection and repair.
Additional Manufacturer Narrative
The radiometer investigation has shown that when looking into the pat log, a 1070 error, sensor response error, is shown.This error is typically shown because of the presence of an obstacle, like a clot or a bubble, in front of the sensor.In the ifu, it states that the action after a 1070 error is shown is to repeat the measurement.The qc logs do not show any abnormal functioning of the sensors.Because of the lack of cal log and sys msg covering the date of the complained result, it cannot be fully confirmed that the sensor was working according to specifications.Hence, root cause is unknown.

• 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: 22870722
• Report Number: 3002807968-2025-00110
• Device Sequence Number: 9091781
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1060N034
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120197
• 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): 09/30/2025

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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: 74 YR
• Patient Sex: Male