BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2831562 · Received November 14, 2012

    Report

    Report Number
    2050012-2012-01811
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED FILTERS ON WASH STATIONS, CUVETTE WASH, AND HYDRO LINES 10 AND 16. THE FSE VERIFIED SYSTEM PERFORMANCE. FAILURE MODE DETERMINED TO BE PLUGGED WASTE LINE FILTERS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT SAMPLE AND REAGENT WASH STATIONS OVERFLOWED DUE TO PLUGGED WASTE LINE FILTERS ON IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO ERROR MESSAGES, FLAGS OR QC OUTSIDE ACCEPTABLE LIMITS WERE OBSERVED PRIOR TO DISCOVERY OF THE LEAKING. THERE WAS NO EXPOSURE OR INJURIES TO THE OPERATORS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED OR REPORTED DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1