MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number	393-800
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, on (b)(6) 2023 when using an (b)(6) the customer reported a potential bias for na (sodium) on this analyzer which is undetected by calibration and both internal and external qc.All patient results were elevated by 6-10 mmol/l in reference to the lab value.Abl800 lab unit 148 137 mmol/l.153 136 mmol/l.148 130 mmol/l.156 145 mmol/l.The customer reported the 4 results from the abl800 as false high.
Additional Manufacturer Narrative
Ongoing radiometer investigation on the 2023-06-13, of the received data logs indicate that the cause of the issue is an obstruction, which likely was caused by a clot in the fluidic pathway.New information regarding the abl800 analyzer was received on 2023-06-14, where installation of new sodium electrodes have not resolved the discrepancy.Hence further testing and investigations is planned and ongoing as the radiometer field service engineer is in the process of installing new electrodes/module, and gathering new information.
Additional Manufacturer Narrative
The radiometer investigation has not been able to establish the root cause, hence the root cause remains unknown.

• Brand Name: ABL800 FLEX 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: cecilie jensen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16775059
• Report Number: 3002807968-2023-00015
• Device Sequence Number: 15137435
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1201N004
• 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): 08/08/2023

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: 393-800
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/31/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 07/07/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2011
• 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