BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ200

    MDR report key: 4030360 · Received July 29, 2014

    Report

    Report Number
    2023446-2014-00100
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IQ200 AUTOMATED URINE MICROSCOPY ANALYZER REPORTING FALSE NEGATIVE/FALSE LOW CELLS (RBCS AND WBCS) FOR (B)(6) PATIENT SAMPLES. NONE WERE REPORTED OUT TO LIS OR PATIENT. NO CHANGE IN PATIENT MANAGEMENT, NO LOSS OF PATIENT TO FOLLOW UP OR IMMATURE DISCHARGE WERE REPORTED DUE TO ERRONEOUS RESULT. NO INJURIES WERE REPORTED. PER CUSTOMER, THE CHEM/MICRO CORRELATION ALERT WAS TURNED OFF. THE CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO CHANGE THE SAMPLE FILTER; THE IQ200 NOW FOCUSED FINE AND THE QC PASSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILURE IN AUTO FOCUS WHERE NO CELLS WERE SEEN ON THE IQ200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442490 IQ200 AUTOMATED URINE MICROSCOPY ANALYZER KQO IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1