BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1853346 · Received October 5, 2010

    Report

    Report Number
    2050012-2010-00899
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 11, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI HOTLINE HAD THE CUSTOMER PRESS STOP AND HOME FUNCTIONS. PER CUSTOMER, ALL MC CUPS AND ISE CALIBRATED AND NOW THERE IS NO LEAK.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING WASTE DRAIN OVERFLOW AT THE MODULAR CHEMISTRIES (MC) SIDE ON THE SYNCHRON LX I 725 CLINICAL SYSTEM. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1