MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number	393-092
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event estimated.
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the customer experienced sporadically issues with the barcode scanner, where digits were cut off.The abl90 flex plus analyzer (serial number (b)(6) sporadically reads only the first two digits of the barcode and cuts off the remaining digits.New information received 17mar2026: the patient's name is scanned to identify the blood gas analysis, but a different name appears on the printout.The number 11 appears in the patient id field! this occurs repeatedly in irregular and rare measurements.The clinic and, subsequently, the manufacturer's technician carry out unsuccessful troubleshooting, but the technician learns from one of his colleagues that he is aware of other rare, similar cases.All of them have the patient id (b)(6).

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Common Device Name: ABL90 FLEX PLUS 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: 24739635
• Report Number: 3002807968-2026-00038
• Device Sequence Number: 13309765
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0337N022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160153
• 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): 03/31/2026

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: 393-092
• Device Catalogue Number: 393-092
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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