MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Codes	High Readings (2459); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint on (b)(6) 2021 the customer noticed false high measurements of sodium on five patients on a abl800 flex analyzer.The customer noticed that the refence membrane was full of blood and chamber was flooded with blood and leaked into ph electrode chamber.She cleaned up the blood and replaced the membrane, ran calibrations and qc, these passed and the patients after that were good.The qc and calibrations passed in the morning, showing no indication of a problem on the analyzer.The below are the false high measurements of na+.Comparison measurement/expected value is 140mmol/l.Patient 1: 159 mmol/l.Patient 2: 170 mmol/l.Patient 3: 161mmol/l.Patient 4: 157mmol/l.Patient 5: 159mmol/l.No reports of death or serious injury.
Event or Problem Description
According to the complaint on (b)(6) 2021 the customer noticed false high measurements of sodium on five patients on a abl800 flex analyzer.The customer noticed that the refence membrane was full of blood and chamber was flooded with blood and leaked into ph electrode chamber.She cleaned up the blood and replaced the membrane, ran calibrations and qc, these passed and the patients after that were good.The qc and calibrations passed in the morning, showing no indication of a problem on the analyzer.The below are the false high measurements of na+.Comparison measurement/expected value is 140mmol/l.Patient 1: 159 mmol/l.Patient 2: 170 mmol/l.Patient 3: 161mmol/l.Patient 4: 157mmol/l.Patient 5: 159mmol/l.No reports of death or serious injury.
Additional Manufacturer Narrative
The radiometer investigation has shown that it is plausible that the leakage on the reference membrane is the root cause for the deviating measurement performance on sodium.The investigation is ongoing.
Additional Manufacturer Narrative
The radiometer investigation is finalized and the root cause is concluded to be "supplied materials outside specification".

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 FLEX
• 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 kroeyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13009643
• Report Number: 3002807968-2021-00064
• Device Sequence Number: 4848656
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1340N002
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/21/2022

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: 12/08/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 03/25/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/09/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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