BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX ANALYZER

    MDR report key: 16775059 · Received April 20, 2023

    Report

    Report Number
    3002807968-2023-00015
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 12, 2023
    Report Date
    August 8, 2023
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938011
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOMETER INVESTIGATION HAS NOT BEEN ABLE TO ESTABLISH THE ROOT CAUSE, HENCE THE ROOT CAUSE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157425 ABL800 FLEX ANALYZER ABL800 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-800 05700693938011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown