BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL BILIRUBIN

    MDR report key: 1083851 · Received July 29, 2008

    Report

    Report Number
    2018433-2008-00151
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CIG
    PMA / PMN Number
    K060574
    Removal / Correction Number
    2018433-8/20/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL BILIRUBIN QUANTITATION OF TOTAL BILIRUBIN CIG ABBOTT MANUFACTURING, INC. NA 59074HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI