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	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to complaint, the hospital reported that on (b)(6) 2025, after drawing an arterial blood gas sample, the nurse found that the patient's po2 was too low on abl90 flex analyzer (serial number: (b)(6)).

• Brand Name: ABL90 FLEX ANALYZER
• Common Device Name: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: anette gram ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 24019229
• Report Number: 3002807968-2026-00005
• Device Sequence Number: 10583683
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1182N029
• 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): 02/25/2026

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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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: 70 YR
• Patient Sex: Female