BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU643-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1840512 · Received September 21, 2010

    Report

    Report Number
    2050012-2010-00830
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND REPLACED A DEFECTIVE VACUUM PUMP DIAPHRAGM. INSTRUMENT PERFORMANCE ISSUES WERE DUE TO WASH STATION MALFUNCTION THAT WAS CAUSED BY THE VACUUM PUMP DIAPHRAGM FAILURE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING 3 URINE MTP RESULTS GENERATED BY THE AU 643-02E CLINICAL CHEMISTRY ANALYZER THAT WERE REVISED LOWER. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU643-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1