BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1900770 · Received November 16, 2010

    Report

    Report Number
    2050012-2010-01295
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS ORDERED TO REPLACE THE SYRINGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAK COMING FROM THE BOTTOM OF THE WASH SYRINGE IN THE SYNCHRON LX I 725 CLINICAL SYSTEM. NO OPERATOR EXPOSURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX® I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX® I 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1