BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1981726 · Received February 8, 2011

    Report

    Report Number
    2050012-2011-00399
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011, AND FOUND THE LEAK COMING FROM THE REAGENT MANIFOLD. THE FIELD SERVICE ENGINEER (FSE) REMOVED ALL REAGENT BOTTLES, AND CLEANED UP THE FLUID THAT HAD LEAKED FROM THE 1/4 INCH PLUG ON THE REAGENT MANIFOLD. THE FSE REPLACED THE PLUG AND THE LEAK SUBSIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THE LEAK WAS INSIDE MODULAR CHEMISTRY REAGENT COMPARTMENT. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1