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

Model Number	393-801
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the customer reported that they were in the process of investigating a serious potassium discrepant result reported from abl800 flex analyzer (serial number (b)(6).On (b)(6)2024, a potassium of 9.5 was resulted from the abl800 flex analyzer.The provider called questioning the result to which the technologist repeated the sample on abl837-a to which the potassium was 3.2.Both analyzers had successful qc run at 0700 that morning.The abl800 flex analyzer (serial number (b)(6) also had a successful 2-point calibration at 9am.
Event or Problem Description
According to the complaint, the customer reported that they were in the process of investigating a serious potassium discrepant result reported from abl800 flex analyzer (serial number (b)(6)).On (b)(6) 2024, a potassium of 9.5 mmol/l was resulted from the abl800 flex analyzer.The provider called questioning the result to which the technologist repeated the sample on abl837-a to which the potassium was 3.2 mmol/l.Both analyzers had successful qc run at 0700 that morning.The abl800 flex analyzer (serial number (b)(6)) also had a successful 2-point calibration at 9am.
Additional Manufacturer Narrative
Information about units received and added in b5.
Additional Manufacturer Narrative
Radiometer investigation concluded that the incorrect measurement of multiple parameters was due to a clot.Hence it was a pre-analytical issue.

• Brand Name: ABL800 FLEX WITH ANALYZER
• Common Device Name: ABL800 FLEX 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 21077923
• Report Number: 3002807968-2025-00002
• Device Sequence Number: 6916674
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2549N012
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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): 03/04/2025

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: 393-801
• Device Catalogue Number: 393-801
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/13/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/14/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2018
• 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: Male