BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER

    MDR report key: 1329132 · Received February 27, 2009

    Report

    Report Number
    MW5010134
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 13, 2009
    Manufacturer
    IRIS DIAGNOSITICS, A DIVISION OF IRIS INTERNATIONAL, INC.
    Product Code
    KQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AUTOMATED URINALYSIS SYSTEM USING FLOW CYTOMETRY FOR MICROSCOPIC EVALUATION AND REPORTING. THROUGH THE AUTOMATED PROCESS, SPERM FROM THE URINE WAS TRANSFERRED TO THE NEXT SPECIMEN REQUIRING FLOW CYTOMETRY ANALYSIS. THIS CARRYOVER OF SPERM RESULTED IN THE NEXT SPECIMEN GIVING A FALSE POSITIVE RESULT OF SPERM IN A SAMPLE FROM A FEMALE. THE PRESENCE OF SPERM IN URINES FROM FEMALES 14 Y OR UNDER IS A CRITICAL RESULT AND HAS MEDICAL LEGAL IMPLICATIONS FOR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER NONE KQO IRIS DIAGNOSITICS, A DIVISION OF IRIS INTERNATIONAL, INC. IRIS IQ200 ELITE
    2 IRIS IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER NONE KQO IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other