MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX WITH ANALYZER

Model Number	393-800
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the customer experienced during monthly analysis of patient samples for quality control, that na+ and ca2+ were falsely low compared to the laboratory's instrument.This occurred on (b)(6) 2025.On (b)(6) 2025, the customer began troubleshooting this by cleaning the sample path and replacing the membranes.Calibrations and controls were okay, but the difference remained.On (b)(6) 2025, the customer tried replacing the reference electrode and a new comparison was performed but the error remained.Below are the discrepant and comparison measurements all from (b)(6) 2025: na+ 142mmol/l (comparison).Ca2+ 1,12mmol/l (comparison).Na+ 134 mmol/l (discrepant).Ca2+ 0,98mmol/l (discrepant).Information provided on 12jun2025: "the deviating test result has resulted in an extension of the intensive care period for one patient, as the change in the analyzed samples led to the treatment being adjusted when trying to correct for the changed values.Treatment was adjusted due to the incorrect values, which led to extended intensive care for one patient.".
Additional Manufacturer Narrative
The radiometer investigation has found that the most likely reason for the issues experienced is aspiration of blood clot into the instrument, which may have deposited beneath the reference sensor and thereby affected the measurements, calibrations and qcs of sodium and calcium.

• Brand Name: ABL800 FLEX WITH ANALYZER
• Common Device Name: ABL800 FLEX WITH 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: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22289043
• Report Number: 3002807968-2025-00080
• Device Sequence Number: 8929719
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2806N011
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/30/2025

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
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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