MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint (b)(4), on 2025-05-07 and 2025-05-14, the customer was unable to measure po2 for a patient's sample on their abl800 flex (serial number: (b)(6).This patient is on dialysis.No reports of death or serious injury.
Additional Manufacturer Narrative
Radiometer investigations of the provided data logs showed that the analyzer had successfully measured the sample but did not display these values.The analyzer detected that the po2 and the so2 results deviated so much from the standard oxygen dissociation curve (odc) that an error is suspected.Hence, the analyzer had worked as intended and no failure was identified.Therefore, this incident does not meet the criteria for a reportable mdr.

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22175631
• Report Number: 3002807968-2025-00076
• Device Sequence Number: 7818592
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2732N003
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 07/22/2025

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: 393-800
• Device Catalogue Number: 383-800
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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: 42 YR
• Patient Sex: Male