BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 SYSTEM

    MDR report key: 6075554 · Received November 3, 2016

    Report

    Report Number
    2023446-2016-00395
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    UDI-DI
    10837461001324
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PROBLEM WAS THE EVACUATION BYPASS VALVE (EBV). HE REPLACED THE EBV TO RESOLVE THE REPORTED ISSUE. THE REPAIRS WERE VERIFIED AS PER SERVICE PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM: INADVERTENTLY OMITTED FROM ORIGINAL SUBMISSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BODILY FLUID CONTROL FAILURE AND RBC WAS FAILING LOW ON THEIR IQ 200 SYSTEM. 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
    726244 IQ 200 SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA 10837461001324

    Patients

    Seq Age Sex Outcome Treatment
    1