BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2159651 · Received July 12, 2011

    Report

    Report Number
    2050012-2011-02991
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER REPLACED VERTICAL HOME SENSOR AND MIXING PADDLES. FSE REALIGNED MIXER ASSEMBLY AND THIS RESOLVE THE RESOLVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT A LEAK ON THE CARTRIDGE CHEMISTRY (CC) REAGENT MIXER MOTION ERROR AND PUDDLE ON THE CC SIDE OF THE UNICEL DXC 600I INSTRUMENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1