BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 1694036 · Received May 14, 2010

    Report

    Report Number
    2531779-2010-00265
    Event Type
    Death
    Date Received
    May 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S PHYSICIAN ADVISED THAT AT THE TIME OF THE EVENT THE PUMP CARTRIDGE WAS FOUND TO HAVE 120 UNITS OF INSULIN REMAINING. THE PT'S PHYSICIAN WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS REGARDING THE EVENT AND WAS UNWILLING TO PROVIDE PT INFO TO ANIMAS. THE PT'S PHYSICIAN ADVISED SHE WOULD REQUEST THE FAMILY CONTACT ANIMAS DIRECTLY, BUT TO DATE NO CONTACTS OF THIS NATURE HAVE BEEN RECEIVED. ANIMAS HAS BEEN UNABLE TO IDENTIFY THE PT OR OBTAIN ADDITIONAL INFO REGARDING THE EVENT OR PUMP FUNCTION. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAS INSULIN PUMP PT RECENTLY PASSED AWAY. THE PT WAS REPORTED TO HAVE HAD A HISTORY OF HYPOGLYCEMIC EVENTS. NO ADDITIONAL INFO REGARDING THE PT IDENTITY, EVENT DETAILS, OR CAUSE OF DEATH ARE CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INSULIN INFUSION PUMP LZG ANIMAS CORP. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death