MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4) according to the complaint the hospital reported, on (b)(6) 2025, at 5:30 pm, after collecting the patient's arterial blood, testing was performed.Five minutes later, the abl90 flex analyzer did not produce any results, delaying the patient's treatment.After replacing the sensor cassette (lot number: r0330) and retesting, the system returned to normal.New information received on (b)(6) 2025: confirmed sequence of events: before the measurement, the analyzer did not issue any alarms and was in normal status.The customer loaded the sample onto the analyzer and then left, waiting for the measurement to be completed automatically.Approximately a few minutes later, the customer returned to the analyzer to check the measurement results and found that no result had been generated.The analyzer displayed error code 1311.The customer then reinstalled the sc, but the analyzer displayed an alarm the chip data cannot be read.Finally, after the customer replaced the sc with a new one and installed it, the issue was resolved.The customer recollected the patient sample and completed the measurement.

• 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: 23955626
• Report Number: 3002807968-2026-00001
• Device Sequence Number: 9448449
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1139N004
• 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
• Report Date (Section B): 01/05/2026

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: 12/25/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2022
• 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 Sex: Unknown