MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL827 FLEX PLUS

Model Number	393-801
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, incorrect thb results was measured on two blood gas samples on abl827 flex plus analyzer ((b)(6)): sample # (b)(6): abl analyzer incorrect result: 27g/l, lab analyzer comparison result: 118g/l sample # 108567: abl analyzer incorrect result 121g/l, lab analyzer comparison result 67g/l sample # (b)(6) is considered false high and sample (b)(6) is considered false low.
Additional Manufacturer Narrative
Investigation concluded that no data indicates that there is errors on the oximetri module.Data points to possible air bubbles or cloth could be trapped inside the cuvette.These can be removed by doing persistent rinse of the liquid transport system.
Additional Manufacturer Narrative
Correction made to investigation finding and investigation conclusion codes.

• Brand Name: ABL827 FLEX PLUS
• Common Device Name: ABL827 FLEX PLUS
• 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: christoffer thaysen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16982134
• Report Number: 3002807968-2023-00019
• Device Sequence Number: 6762773
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2551N014
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 08/11/2023

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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/20/2023; 07/17/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/29/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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: Unknown