BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS +

    MDR report key: 3190073 · Received June 20, 2013

    Report

    Report Number
    1217157-2013-00107
    Event Type
    Other
    Date Received
    June 20, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT BLOOD RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE BLOOD ON THE INSTRUMENT BUT THE CULTURE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280923 CLINITEK STATUS + CT STATUS + JIL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1