BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 15543290 · Received October 5, 2022

    Report

    Report Number
    9612296-2022-00313
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    14987666543016
    PMA / PMN Number
    K112412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS (B)(6). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU5800 CLINICAL CHEMISTRY ANALYZER. FSE CONFIRMED CUSTOMER¿S ISSUE. FSE OBSERVED 3641 PHOTOMETRY ERROR DURING CUVETTE WASH, FOUND BROKEN CUVETTE GLASS IN THE WHEEL AND OUTER CUVETTES FAILING PHOTOCAL. FSE CLEANED ALL CUVETTES, INSPECTED WASH NOZZLE, INSPECTED AND CLEANED THE CUVETTE WHEEL. FSE REPLACED PCBA PULSE MOTOR CONTROL, 271BPMC1A BELLOWS AND DIA LID PIN WHICH RESOLVED THE ISSUE. FSE RAN PHOTOCAL AND QUALITY CONTROL WITH NO ISSUE. FSE VERIFIED SERVICE TASK. IN CONCLUSION, THE CAUSE OF THE EVENT IS A HARDWARE MALFUNCTION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ERRONEOUS LOW AND FLAGGED PATIENT RESULTS FOR ALT(ALANINE AMINOTRANSFERASE), BUN (BLOOD UREA NITROGEN), CO2 (CARBON DIOXIDE) AND TBIL (TOTAL BILIRUBIN) AND GETTING PHOTOMETRY ERRORS DURING CUVETTE WASH ON THE CUSTOMER'S AU5800 (AU5800-10 CHEMISTRY ANALYZER, PART NUMBER B96697 AND SERIAL NUMBER (B)(4). THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS SYSTEM PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418554 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5800-10 CHEMISTRY ANALYZER AU5800 14987666543016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown