BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1980513 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00385
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SYRINGES THAT APPEARED TO BE LEAKING PAST THE PLUNGER AND HAVE BUFFER BUILD UP. FSE REROUTED THE OVERFLOW TRAY TUBING, WHICH HAD CAUSED FLUID IN THE TRAY TO NOT DRAIN PROPERLY. REPLACED LEAKING WASH STATION RINSE AND DRAIN TUBING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CLOSE TUBE ACCESSION (CTA) WASH STATION LEAK. NO AFFECT TO ANY PERSONNEL OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1