BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 661602 · Received January 9, 2006

    Report

    Report Number
    2531779-2006-00009
    Event Type
    Death
    Date Received
    January 9, 2006
    Date of Event
    December 2, 2005
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT THE PT WAS HOSPITALIZED WITH DKA IN 2005 AND SUBSEQUENTLY PASSED AWAY SEVENTEEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death| H