BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1951765 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00078
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THE GLU MODULE SENSOR WAS REPLACED, WHICH WAS NOT SECURE PROPERLY AND LEAKED. CUSTOMER ATTEMPTED TO FIX THE ISSUE, BUT THE LEAK WAS ENOUGH DOWN SIDE OF MODULE FLUID, WHICH MADE CONTACT WITH INTERFACE CABLES ON THE MODULE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE GLU MODULE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE GLUCOSE (GLUC) REAGENT WAS LEAKING AT THE CUP LOCATED IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1