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

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	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the intensive care unit has created a phh (potential health hazard) on sample 4152 analyzed on a abl800 flex analyzer (serial no; (b)(6)) the (b)(6)2025 at 8:34.They have registered the sample in flexlink on pc as a venous sample, but when sampling the sample on the abl800 flex analyzer, it is automatically registered as an arterial sample, and this has been transmitted to lis system, and patient journal.In aqure the results are with sample type venøs.
Additional Manufacturer Narrative
The radiometer investigation has concluded that the event is caused by a use error.Hence, this incident does not meet the criteria of a reportable mdr now.

• 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: 21373515
• Report Number: 3002807968-2025-00009
• Device Sequence Number: 11701940
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2819N023
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 02/14/2025

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
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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