BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3131282 · Received May 13, 2013

    Report

    Report Number
    1217157-2013-00085
    Event Type
    Other
    Date Received
    May 13, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 MICROSCOPIC AND VISUAL RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211816 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR