BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADIVA CHEMISTRY TOTAL PROTEIN REAGENT KIT

    MDR report key: 1196535 · Received October 10, 2008

    Report

    Report Number
    2432235-2008-00118
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    September 12, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REMEDIAL ACTION: THE DEXTRAN INTERFERENCE SECTION IN THE IFU WILL BE REVISED TO REFLECT CURRENT DATA.

    Description of Event or Problem · 1

    DURING STUDIES, IT WAS OBSERVED THAT THE ADVIA CHEMISTRY TOTAL PROTEIN METHOD DID NOT MEET CLAIMS OF NO SIGNIFICANT INTERFERENCE AT 1500 MG/DL DEXTRAN. THERE HAVE BEEN NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO POSITIVE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADIVA CHEMISTRY TOTAL PROTEIN REAGENT KIT TOTAL PROTEIN CHEMISTRY METHOD CEK SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 100789

    Patients

    Seq Age Sex Outcome Treatment
    1