BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1905076 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01341
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, PERFORMED TROUBLESHOOTING AND REPLACED SEVERAL PARTS. THE ISSUE WAS RESOLVED. A CLEAR ROOT CAUSE FOR THIS ISSUE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS GETTING ERROR MESSAGES THAT THE WASTE SUMP WAS NOT DRAINING AND THAT THERE WAS A LEAK IN THE HYDRO AREA. NO INJURY WAS REPORTED.

    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