BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 ANALYZER W/O CAP PIERCER

    MDR report key: 2110741 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01959
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND DISCOVERED THE LEAK WAS COMING FROM A VALVE AND REPLACED CRACKED TUBING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN UNIDENTIFIED LEAK FROM HYDROPNEUMATIC DRAWER IN THE SYNCHRON LX20 ANALYZER. FLUID WAS DRIPPING FROM DRAWER ONTO FLOOR UNDERNEATH THE ANALYZER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 ANALYZER W/O CAP PIERCER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1