BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ200SPRINT

    MDR report key: 2677753 · Received July 29, 2012

    Report

    Report Number
    2677753
    Event Type
    Malfunction
    Date Received
    July 29, 2012
    Date of Event
    May 15, 2012
    Report Date
    July 29, 2012
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    KQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN INSTRUMENTATION ERROR ON THE MICROSCOPIC URINALYSIS. THE TEST WAS REPEATED AND CORRECTIONS MADE TO THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ200SPRINT AUTOMATED URINALYSIS SYSTEM KQO IRIS DIAGNOSTICS IQ200SPRINT *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR