BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO SYSTEM

    MDR report key: 2159632 · Received July 12, 2011

    Report

    Report Number
    2050012-2011-02993
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND 2 DENTS ON THE FACE OF THE ELECTRODE. SERVICE WAS NOT DISPATCHED. THE CUSTOMER WAS SENT A REPLACEMENT TO RESOLVE THE LEAKING ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT A LEAK FROM THE GLUCOSE MODULAR (GLUM) AFTER INSTALLING A NEW GLUCOSE ACCUSENSE ON THE UNICEL DXC 800P SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER REPLACED THE ELECTRODE 1 AND 2 WHEN A DENTS WAS NOTED ON BOTH. NO REPORTS OF INJURY OR EXPOSURE WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1