BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2587809 · Received May 24, 2012

    Report

    Report Number
    2050012-2012-01154
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    April 29, 2012
    Report Date
    April 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL ANALYSIS CONDUCTED BY BECKMAN COULTER, INC. INDICATES THERE WAS NO EVIDENCE OF A SYSTEM MALFUNCTION. NUMEROUS ERROR FLAGS AND SUPPRESSED RESULTS WERE GENERATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE IMMAGE IMMUNOCHEMISTRY SYSTEM GENERATED SUPPRESSED AND ERRONEOUS PATIENT AND CONTROL RESULTS. CUSTOMER REPORTED THAT THERE WERE MULTIPLE OCCURRENCES OF PATIENT SUPPRESSED RESULTS DUE TO VARIOUS ERRORS INCLUDING: OPTICS, E60, E63. CUSTOMER REPORTED THAT THE MORNING START-UP AND CONTROLS WERE ERRATIC AND ERRONEOUS. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE CORRECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE CUVETTE WASTE LINE FILTER WAS PLUGGING AND CAUSING FLUID BUILDUP IN THE CUVETTES. THE FSE REPLACED THE FILTER AND CLEANED THE CUVETTES.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1