BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 SYSTEM

    MDR report key: 6024917 · Received October 12, 2016

    Report

    Report Number
    2023446-2016-00387
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED THAT LEAK WAS COMING FROM A TUBING AT THE PROBE BYPASS VALVE (PBV). HE REPLACED THE TUBING AT THE PBV TO RESOLVE THE LEAK. THE REPAIRS WERE VERIFIED AS PER SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE FLUID LEAKING FROM THE PROBE OF THEIR IQ200 SYSTEM. THE LEAK WAS CONTAINED AND APPROXIMATELY 1ML IN VOLUME. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES, AND GOGGLES. THERE WAS NO DIRECT EXPOSURE TO OPEN WOUNDS OR MUCUOUS MEMBRANES AND NO ONE SOUGHT MEDICAL ATTENTION AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674025 IQ 200 SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1