MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number	393-090
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint ref.(b)(4).According to the complaint, on june 20, 2025, at 10:00 am, the abl90 flex analyzer malfunctioned.An engineer was contacted to inspect the device on-site, and it was diagnosed that the oxi module was faulty.After replacing the spare part, the analyzer returned to normal operation.There were no alarms for calibration and qc and the analyzer did not display as unavailable before the customer checked the sample.Then the customer loaded the sample for testing, and the instrument displayed the test result along with error code 0581 (oxi spectrum mismatch).
Additional Manufacturer Narrative
Investigation of the data logs show that the optical system is functioning normally.Errors in logfiles indicate potential clots, as issues are only related to blood samples, and not blank calibrations.This also explains the errors apparent in the patient logs.But the exact root cause cannot be determined.

• Brand Name: ABL90 FLEX
• Common Device Name: ABL90 FLEX
• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22394203
• Report Number: 3002807968-2025-00087
• Device Sequence Number: 21099835
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0405N007
• 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): 08/07/2025

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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2013
• 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