BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ200

    MDR report key: 4902392 · Received July 2, 2015

    Report

    Report Number
    2023446-2015-00188
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    December 29, 2015
    Report Date
    December 29, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IRIS FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER LOCATION AND THE FSE CONFIRMED INTERMITTENT BLURRINESS OF IMAGES. THE FSE REPLACED THE CAMERA P/N: 700-3565 AND ADJUSTED THE FOCUS. THE FSE RE-RERAN QUALITY CONTROLS AND THE CONTROLS PASSED. THE SYSTEM WAS OPERATIONAL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE IQ200 PATIENT RESULTS FOR MULTIPLE ANALYTES WAS NOT CORRESPONDING TO THE MANUAL MICROSCOPE. THE CUSTOMER ALSO STATED THE IMAGE QUALITY WAS BLURRY. THE CUSTOMER DID RUN CLEANER AND WHEN THE QUALITY CONTROLS WERE RE RUN THE AUTO FOCUS CONTROL FAILED. THERE WERE NO ERRONEOUS RESULTS GENERATED OR REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433204 IQ200 AUTOMATED URINE MICROSCOPY ANALYZER KQO IRIS INTERNATIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1