BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ADVANTUS

    MDR report key: 3261626 · Received July 23, 2013

    Report

    Report Number
    1217157-2013-00139
    Event Type
    Other
    Date Received
    July 23, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOTICS INC.
    Product Code
    JIL
    PMA / PMN Number
    K063276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT WHITE BLOOD CELL (WBC) RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NEGATIVE WHITE BLOOD CELL (WBC) URINE RESULTS ON THE INSTRUMENT WHEREAS MICROSCOPIC RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343541 CLINITEK ADVANTUS CT ADVANTUS JIL SIEMENS HEALTHCARE DIAGNOTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1