BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1800

    MDR report key: 1231151 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08348
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE INSTRUMENT CENTER AG TEGIMENTA
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED FALSE NEGATIVE LEUKOCYTE RESULTS FOR THREE PT SAMPLES. THE FOLLOWING TWO PT EXAMPLES WERE PROVIDED. SAMPLE 1: INITIALLY GAVE NEG FROM ANALYZER, MICROSCOPIC READING GAVE 15-20 WBC/HPF. SAMPLE 2: INITIALLY GAVE NEG FROM ANALYZER, MICROSCOPIC READING GAVE 30-40 WBC/HPF. NO PT RESULTS WERE REPORTED. THE USER WILL ADJUST ANALYZER REFLECTANCE SETTINGS FOR LEUKOCYTES AND VALIDATE THESE CHANGES. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 1800 AUTOMATED URINE ANALYZER - JIL JIL ROCHE INSTRUMENT CENTER AG TEGIMENTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK