BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3092973 · Received May 3, 2013

    Report

    Report Number
    9612296-2013-00059
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    NGS
    PMA / PMN Number
    K112412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE ISE REFERENCE VALVE TO RID AIR BUBBLES IN THE ISE REFERENCE LINE. THE FSE INSPECTED THE ISE SYSTEM AND PROCEEDED TO REPLACE ISE TUBING LINE #5 AND THE SAMPLE D-POT WHEN THE FSE DISCOVERED A CHIP IN THE CUP. THE FSE COMPLETED THE ISE SYSTEM CHECK BY REMOVING AND CLEANING THE ISE FLOWCELL. THE INSTRUMENT WAS CALIBRATED AND PRIMED, AND QC (QUALITY CONTROL) WAS RUN FOLLOWING REPAIRS. QC RESULTS WERE WITHIN THE ESTABLISHED RANGES AND INSTRUMENT'S PERFORMANCE MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO A FAILED ISE REFERENCE VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED OBTAINING INTERMITTENT LOW NA (SODIUM) RESULTS ON CELL #1 INVOLVING THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE AU5800 HAS A DUAL ISE (ION SELECTIVE ELECTRODE) CONSISTING OF CELL #1 AND CELL #2 WHICH FUNCTIONS INDEPENDENTLY WITH THE EXCEPTION OF A COMMON SAMPLE DISPENSE. THE CUSTOMER STATED THAT "A FEW" PATIENT SAMPLES WERE IMPACTED BUT COULD NOT PROVIDE A DEFINITIVE NUMBER OF PATIENT RESULTS WHICH WERE AFFECTED. NO RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED OBSERVING AIR IN THE ISE LINES WHILE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194963 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE NGS BECKMAN COULTER AU5821-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1