BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1951760 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00067
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE CAP PIERCER BLADE BROKEN AND SHAVED PIECES OFF THE BLADE WICK AND CLOGGED THE BLADE WASH DRAIN. THE CUSTOMER TECHNICAL SUPPORT (CTS) BLADE COUNT WAS OVER 87000. THE CUSTOMER ORDERED A REPLACEMENT BLADE. FSE INSTRUCTED THE CUSTOMER ON HOW TO CHANGE THE BLADE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FLUID LEAK FROM THE CAP PIERCER BLADE WASH STATION. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1