BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2180081 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03825
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011, FOR THE EVENT. THE FSE FOUND A CRACK IN THE TUBING. THE FSE REMOVED AND REPLACED IT WITH A NEW TUBING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A LEAK ON THE SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM. THE CUSTOMER REPORTED THAT THE INSTRUMENT STOPPED IN THE MIDDLE OF A RUN AND THE WASH CONCENTRATE BOTTLE WAS EMPTY. THERE WAS A LEAK ON THE FLOOR, WHICH MAY BE FROM THE VENT LINES AT THE HYDRO TRAY. THE CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1