BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 2140278 · Received June 27, 2011

    Report

    Report Number
    2050012-2011-02650
    Date Received
    June 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI SERVICE REPLACED THE WASTE COLLECTOR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A BROKEN WASTE COLLECTOR AND A LEAK FROM THE HYDRO WHEN RUNNING THE INSTRUMENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1