BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 1080654 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05650
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT URINE RESULTS FOR ERYTHROCYTES OR LEUKOCYTES. PATIENT 1, INITIAL RESULT FOR ERYTHROCYTES WAS NEGATIVE. SAME SAMPLE REPEATED USING VISUAL METHODOLOGY WAS NEGATIVE, USING MICROSCOPIC METHODOLOGY GAVE 12 RBC/HPF AND 1-2 RBC/HPF. PATIENT 2, INITIAL RESULT FOR LEUKOCYTES WAS NEGATIVE. SAME SAMPLE REPEATED USING VISUAL METHODOLOGY WAS 3+, USING MICROSCOPIC METHODOLOGY GAVE 12 WBC/HPF AND 12-14 WBC/HPF. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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 UNK