BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2120799 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02194
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE CARTRIDGE CHEMISTRY (CC) SAMPLE WASH VACUUM VALVE AND REBUILT BOTH COMPRESSORS. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THEY OBSERVED "BUBBLES" AND FLUID IN THE WASH COLLAR OF THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM CLOSE TO THE BOTTOM EDGE OF THE COLLAR. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1