BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL SYSTEM

    MDR report key: 2001964 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00575
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER PERFORM TROUBLESHOOTING BUT COULD NOT DETERMINE THE SOURCE OF THE LEAK. BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2011, AND REPLACED HYDRO VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAK FROM THE HYDRO ASSEMBLY ON SYNCHRON LX20 CLINICAL SYSTEM. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LX20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1