BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2150007 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02836
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND NARROWED THE PROBLEM DOWN TO THE VACUUM PUMP AFTER COMMUNICATING WITH THE CUSTOMER. FSE REBUILT THE VACUUM PUMP AND REPLACED 2 CHECK VALVES AND 2 FILTERS. THE VACUUM SYSTEM WAS FUNCTIONING PROPERLY FOLLOWING REPAIRS. FSE ALSO REPLACED THE SAMPLE AND REAGENT PROBES. INSTRUMENT ALIGNMENTS WERE REWORKED AND CALIBRATIONS WERE PERFORMED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A FLUID LEAK IN THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE SAMPLE AND REAGENT PROBE WASH STATIONS WERE OVERFLOWING. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1