BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2395375 · Received January 3, 2012

    Report

    Report Number
    2050012-2011-08587
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: RESTRICTOR. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE WASH CUP FOR THE SAMPLE AND THE WASH CUP ON THE REAGENT SIDE WERE OVERFLOWING ON THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE VACUUM SOLENOID VALVE WAS NOT CREATING SUFFICIENT VACUUM. THE FSE REPLACED THE VACUUM SOLENOID VALVE, THE INLINE FILTER AND THE 0.040 RESTRICTOR. THE FSE VERIFIED THE REPAIR WAS PERFORMED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1