BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2233862 · Received September 4, 2011

    Report

    Report Number
    2050012-2011-05147
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE 500 UL SYRINGE, T-VALVE, AND SMART MODULE. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT A FLUID LEAK WAS OBSERVED UNDER THE REAGENT PROBE A IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT WAS GENERATING CHEMISTRY CARTRIDGE (CC) REAGENT SYRINGE MOTION ERRORS. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1