BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 5165766 · Received October 21, 2015

    Report

    Report Number
    9612296-2015-00090
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE INSTRUMENT. FSE FOUND A DETERGENT VALVE HAD MALFUNCTIONED. FSE REPLACED THE DETERGENT VALVE. THIS RESOLVED THE CUSTOMER'S ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 50 (FIFTY) ERRONEOUS PATIENT RESULTS WERE GENERATED ON INSTRUMENT AU5400 CLINICAL CHEMISTRY ANALYZER. CUSTOMER STATED ERRONEOUS CREATININE AND LIH (LIPEMIA, ICTERUS AND HAEMOLYTIC) RESULTS WERE GENERATED. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON QUALITY CONTROLS. THERE WAS NO CHANGE TO PATIENT TREATMENT DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697064 AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1