BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1979669 · Received February 6, 2011

    Report

    Report Number
    2050012-2011-00353
    Event Type
    Malfunction
    Date Received
    February 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND FOUND OUT THAT WASH DRAIN TUBING CAME OFF AND RECONNECTED THE TUBING AND THIS ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), REGARDING HAVING LEAKS FROM THE HYDRO SYSTEM ON IMMAGE ANALYZER. NO ONE IN THE LABORATORY WAS AFFECTED OR EXPOSED BY THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM NEPHELOMETER/IMMUNOCHEMISTRY SYSTEM JQX BECKMAN COULTER INC. IMMAGE

    Patients

    Seq Age Sex Outcome Treatment
    1