BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2233861 · Received September 4, 2011

    Report

    Report Number
    2050012-2011-05146
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED A "CLOGGED" FILTER IN THE PROBE RINSE WELL VACUUM LINE. THE FSE VERIFIED REPAIRS BY PRIMING SEVERAL TIMES AND MANUALLY ACTIVATING PROBE RINSE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT WASH SOLUTION WAS OVERFLOWING FROM THE SAMPLE PROBE WASH STATION IN THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO ERRORS WERE GENERATED BY THE INSTRUMENT DURING THE LEAKING. NO OPERATOR EXPOSURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. IMMAGE 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1