BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2840877 · Received November 20, 2012

    Report

    Report Number
    2050012-2012-01836
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(6) 2012. THE FSE INSPECTED THE INSTRUMENT AND IDENTIFIED AN IMPROPERLY SEATED HAMILTON VALVE. NO ACTIVE LEAKING WAS OBSERVED AT THAT TIME. THE FSE REMOVED AND REPLACED THE HAMILTON VALVE. FAILURE MODE OF THIS EVENT WAS LOOSE/IMPROPERLY SEATED VALVE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THE REAGENT PROBES WERE LEAKING ON THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. THE LEAK WAS CONTAINED TO THE INSTRUMENT; FLUID WAS NOTED ON THE REAGENT PROBE DRIP TRAY. THE LABORATORY PERSONNEL WAS WEARING LABORATORY COATS AND GLOVES. NO INJURIES WERE SUSTAINED BY ANY LAB PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1