BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM BILIRUBIN CALIBRATOR

    MDR report key: 1132782 · Received August 19, 2008

    Report

    Report Number
    2018433-2008-00159
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JIX
    PMA / PMN Number
    K981706
    Removal / Correction Number
    2018433-8/20/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIN CHEM BILIRUBIN CALIBRATOR FOR USE IN THE CALIBRATION OF THE BILIRUBIN ASSAYS JIX ABBOTT MANUFACTURING, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI