BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1915989 · Received December 6, 2010

    Report

    Report Number
    2050012-2010-01536
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 2010
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CLEANED UP THE SPILL AND REPLACED THE Y CONNECTOR. THE FSE ALSO CHECKED ALL THE FITTINGS AND PRIMED THE SYSTEM. THE SYSTEM IS NOW WORKING UNDER OPERABLE CONDITIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THE NO FOAM SOLUTION WAS LEAKING IN THE HYDRO AREA DUE TO A BROKEN Y-CONNECTOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1