BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5CE CLINICAL SYSTEM

    MDR report key: 1871827 · Received October 16, 2010

    Report

    Report Number
    2050012-2010-00984
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K926060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT. BCI CTS (CUSTOMER TECHNICAL SUPPORT) REQUESTED CUSTOMER TO SHIP THE REAGENT BOTTLE BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT A WASH CONCENTRATE BOTTLE LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5CE CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA T006110

    Patients

    Seq Age Sex Outcome Treatment
    1