BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1060405 · Received June 13, 2008

    Report

    Report Number
    2531779-2008-00335
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. THE PT'S SPOUSE REPORTED THAT THE PT WAS THROWN FROM THE VEHICLE AND THE PUMP HAS NOT BEEN RECOVERED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP, AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PT'S SPOUSE ALSO REPORTED THAT THE POST MORTEM BLOOD GLUCOSE VALUE EXHIBITED HYPOGLYCEMIA. NO ADD'L INFO IS AVAILABLE REGARDING THE TIME THIS POST MORTEM TEST WAS CONDUCTED OR THE TEST METHOD UTILIZED. IF THE DEVICE IS RECOVERED AND RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT WAS INVOLVED IN A FATAL AUTOMOBILE ACCIDENT. THE PT'S SPOUSE REPORTED THAT A HYPOGLYCEMIC BLOOD GLUCOSE VALUE WAS OBTAINED POST MORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Death