BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2240188 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05090
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED TROUBLESHOOTING WITH BEC CTS (CUSTOMER TECHNICAL SUPPORT) AND NOTED THAT THE SAMPLE AND REAGENT PROBE WASH STATIONS WERE NOT DRAINING AND OVERFLOWING AS A RESULT OF A LACK OF VACUUM. CTS GENERATED A SERVICE REQUEST. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPLACED A DIAPHRAGM DUE TO THE LOW VACUUM ISSUE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE SAMPLES AND REAGENT PROBE WASH STATIONS IN THE IMMAGE IMMUNOCHEMISTRY SYSTEM WERE NOT DRAINING AND WERE OVERFLOWING. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1