BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1083852 · Received July 29, 2008

    Report

    Report Number
    1628664-2008-00180
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK