BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 1070456 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05227
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PTS WITH DISCREPANT URINE RESULTS FOR LEUKOCYTES. BOTH PTS HAD NEGATIVE RESULTS WHEN USING THE STRIP SCREENING TEST AND WERE THEN EXAMINED MICROSCOPICALLY YIELDING > 20 WBC/HPF. THE INITIAL RESULTS WERE NOT REPORTED. THE CUSTOMER ALIGNED THE PROBE WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 2400 AUTOMATED URINE ANALYZER - JIL JIL ROCHE DIAGNOSTICS U2400

    Patients

    Seq Age Sex Outcome Treatment
    1