BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1100

    MDR report key: 1006896 · Received February 25, 2008

    Report

    Report Number
    1823260-2008-01843
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    K033548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ONE PT URINE SAMPLE THAT RESULTED NEGATIVE FOR BLOOD. VISUAL DIPSTICK OF SAME SHOWED 2+ OR 3+ FOR BLOOD. URINE SAMPLE REPEATED AN ADD'L TIME GIVING THE SAME RESULTS. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 1100 AUTOMATED URINE ANALYZER JIO ROCHE DIAGNOSTICS U1100

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR