MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated based on manufacturer's awareness date.
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, the customer experienced sporadically aborted measurements on the abl800 flex (serial number: (b)(6).Radiometer field service engineer had checked the data logs and activity logs of the analyzer and could not find the information regarding the aborted measurements.10 test measurements were conducted without issue.Several maintenance and service were conducted with no issue.

• 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: 24829483
• Report Number: 3002807968-2026-00042
• Device Sequence Number: 18438560
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2859N018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/11/2026

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: 393-800
• Device Catalogue Number: 393-800
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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