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	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of incident is estimated on manufacture's awarness date of incident which is 2026-04-03.The information received by manufacturer that made this complaint reportable is 2026-04-30.
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, the electrolyte measurements (sodium cna+) from the abl90 flex analyzer (serial number: (b)(6) are different from the measurements obtained from another instrument on the same samples.

• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 25158341
• Report Number: 3002807968-2026-00057
• Device Sequence Number: 9453214
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1285N024
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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