BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2141912 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02651
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCE FIELD SERVICE ENGINEER (FSE) FOUND THE FLUID LEAK COMING FROM THE SAMPLE WASH COLLAR. FSE CLEANED THE WASH COLLAR WASTE VALVE AND CLEANED ALL CUVETTES. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) IN REGARDS TO FAILING WATER BLANK TESTS, CARTRIDGE CHEMISTRY LEAK, AND NO VACUUM AT THE WASH COLLAR. NO INJURY OR EXPOSURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON® CHEMISTRY ANALYZER DISCRETE CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1