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

Model Number	393-800
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is estimated as the first issue the customer experience occurs on (b)(6) 2025.Hence, the case is created at this date (awareness date).The problem then occurs again 0n (b)(6) 2025 and the measurements are obtained at this date and reflected in this report.
Event or Problem Description
According to the complaint the customer experienced not reliable results on ph, ca and k.However, only the below measurements have been provided for ph and sbe: (b)(6) 2025, 04:20 ph 6.997 (discrepant), (b)(6) 2025, 05:17 ph 7.027 (discrepant), (b)(6) 2025, 05:52 ph 7.065 (discrepant), (b)(6) 2025, 06:20 ph 7.360 (comparison measurement).(b)(6) 2025, 04:20 sbe -19.9mmol/l (discrepant), (b)(6) 2025, 05:17 sbe -19.5mmol/l (discrepant), (b)(6) 2025, 05:52 sbe -17.8mmol/l (discrepant), (b)(6) 2025, 06:20 sbe -3.3mmol/l (comparison measurement).According to the customer, the issues for ca and k are fixed.
Additional Manufacturer Narrative
The customer has on 21feb2025 provided the following additional measurements, which they do not believe (discrepant measurements).Cna+ 104mmol/l (expected 139mmol/l), ccl- 83mmol/l (expected 110mmol/l) and cthb 7,8g/dl (10,7g/dl).The radiometer investigation is still in progress.
Additional Manufacturer Narrative
The radiometer investigation is completed.The review of the device data revealed a problem with the ph calibration experienced as sensitivity errors and shift in status values on 2025-02-05 shortly after discrepant measurements with ph were experienced.The errors identified indicate that, e.G.Contamination or leakage in the ph measuring chamber probably impacted the sensor signal.Upon investigation of the customer device (externally at the facility of level 1), it was determined that the ph/bg (blood gas analyzer) measuring chamber was broken.It is believed that the defective measuring chamber is the probable cause of the described error modes (contamination or leakage), which may both have impacted the sensor signals and altered the sample composition.

• 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: 21372381
• Report Number: 3002807968-2025-00008
• Device Sequence Number: 20969905
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2329N006
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 04/11/2025

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: 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: 02/03/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 03/28/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/17/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2016
• 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