BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1913046 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01442
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED LEAKING REAGENT T VALVE AND REMOVED BUBBLES FROM REAGENT SYRINGE. THE FSE INSPECTED THE INSTRUMENT, PRIMED LINES, AND RAN QC. HARDWARE, ADDRESSED BY THE FSE, IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEY RECEIVED CUVETTE NOT DRY ERRORS ON SYNCHRON LX I 725 CLINICAL SYSTEM. WHEN TROUBLESHOOTING, THE CUSTOMER NOTICED DROPS OF FLUID ON TOP OF THE REAGENT CAROUSEL COVER. 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