BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2855139 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01896
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM LEAKED A CLEAR AND ODORLESS FLUID FROM THE SAMPLE DRAIN UNDER THE PROBE. THE FLUID DRIPPED ONTO THE FLOOR. THE CUSTOMER WAS WEARING GLOVES AND EYE PROTECTION WHEN THE LEAK WAS DISCOVERED. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EMERGENCY CHEMICAL SPILL PLAN IN PLACE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED A SAMPLE PROBE WASH STATION OVERFLOW. THE FSE REPLACED BOTH WASH STATION WASTE FILTERS AND THE CUVETTE WASH STATION WASTE FILTER. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE JQX BECKMAN COULTER, INC. IMMAGE 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1