MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference (b)(4).According to complaint, the customer complains about a white screen during sample measurement by using abl800 (serial number (b)(6) flexq module and abortion of sample.An operator placed a sample into flexq module and logged off.During sample measurement of above-mentioned sample another operator put a further sample into flexq module followed by entry of patient data.After entry of patient data, the analyzer screen turns white, but analyzer unit (au) continued working.After completion of au activities, the operator restarted the analyzer.The running measurement was aborted but the analyzer worked without problems and as intended after restart.No adverse event or serious injury were identified.
Additional Manufacturer Narrative
This complaint occured on 18oct2023 and was re-opened on 09oct2025 in an internal quality review and reassessed in relation to a capa (capa-01335).It is now deemed reportable.
Additional Manufacturer Narrative
The radiometer investigations have concluded that the problem was solved after re-installing the operational system (os) and software (sw).

• 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: bernarda radoncic ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23356881
• Report Number: 3002807968-2025-00127
• Device Sequence Number: 21038742
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2819N011
• 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): 11/14/2025

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
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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