BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 SYSTEM

    MDR report key: 6091608 · Received November 9, 2016

    Report

    Report Number
    2023446-2016-00400
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 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 THE SOURCE OF THE LEAK WAS THE LAMINA BYPASS VALVE (LBV). THE FSE REPLACED THE LBV AND THEN PRIMED THE SYSTEM 10 TIMES AND DID NOT SEE ANY MORE LEAKAGE. THE FSE ALSO AN FOCUS AND IT PASSED AND RAN QC TWICE AND BOTH TIMES PASSED AS WELL. THE REPAIRS WERE VERIFIED AS PER SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN UNCONTAINED FLUID LEAK OF ABOUT 10ML COMING FROM THEIR IQ 200 SYSTEM. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF LEAK DISCOVERY. THERE WAS NO DIRECT EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED. THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739866 IQ 200 SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1