MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number	393-801
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference: (b)(4).According to the complaint, on (b)(6) 2025 the user experienced discrepant measurements on the abl800 flex analyzer (serial number: (b)(6)), possibly due to a clot.On (b)(6) 2025 - 23:53 - clot possibly introduced into analyzer.Sample status was 'interrupted.' (no messages present) on (b)(6) 2025 - 23:56 - sample aborted (0328 no leading air segment in inlets liquid sensor within time frame).On (b)(6) 2025 - 00:29 - sample aborted (0328 no leading air segment in inlets liquid sensor within time frame).No reports of death or serious injury.
Additional Manufacturer Narrative
Radiometer investigations have concluded the root cause to be a pre-analytical error.

• Brand Name: ABL800 FLEX ANALYZER
• Common Device Name: ABL800 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: 22949366
• Report Number: 3002807968-2025-00111
• Device Sequence Number: 8529652
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2866N022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041874
• 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): 10/09/2025

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: 393-801
• Device Catalogue Number: 393-801
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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