BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 1191585 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07296
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING NEGATIVE RESULTS FOR ERYTHROCYTES. TWO PATIENT SAMPLES WERE INVOLVED. SAMPLE 1 GAVE NEGATIVE RESULT, WHEN EXAMINED MICROSCOPICALLY SHOWED 10-20 CELLS/HPF. SAME SAMPLE REPEATED WITH CHEMSTRIP GAVE TRACE RESULT. SAMPLE 2 TESTED IN 2008 GAVE NEGATIVE RESULT, WHEN EXAMINED MICROSCOPICALLY SHOWED 10-20 CELLS/HPF. SAME SAMPLE REPEATED WITH CHEMSTRIP GAVE TRACE RESULT. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE, BUT NOTED HE CHECKED THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK