BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ200

    MDR report key: 3897480 · Received May 22, 2014

    Report

    Report Number
    2023446-2014-00056
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARED THE SAMPLE PROBE TUBING TO THE SAMPLE FILTER WAS BROKEN AND LEAKING; POSSIBLE BIOHAZARDOUS. THE SMALL LEAK WAS CONTAINED TO THE BENCH TOP, AND NO ONE WAS EXPOSED. FSE REPLACED PIPETTE AND FITTINGS AND SYSTEM TESTED SUCCESSFULLY. THIS TUBING HOUSES PATIENT URINE SPECIMEN AS WELL AS LAMINA. LAMINA CAN LEAK INTO THE PATIENT SAMPLE DILUTING IT TO CREATE A POTENTIAL FALSE LOW/FALSE NEGATIVE CELL/SEDIMENT COUNT. NO INJURIES WERE REPORTED NOR CHANGE TO PATIENT MANAGEMENT. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SAMPLE PROBE WAS DRIPPING LAMINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306991 IQ200 AUTOMATED URINE MICROSCOPY ANALYZER KQO IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1