BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2141877 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02515
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 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
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) CHECKED REAGENT CAROUSEL DRAIN LINES, FITTINGS AND GRAVITY DRAIN; NO PINCHING OR PLUGS WERE FOUND. THE FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT THEY FOUND 1/2 INCH OF FLUID ON THE TRAY BELOW THE BOTTOM OF REAGENT CAROUSEL IN UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1