BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1083266 · Received July 28, 2008

    Report

    Report Number
    2531779-2008-00417
    Event Type
    Death
    Date Received
    July 28, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP, AND IT WAS OPERATING WITHIN REQUIRED SPECS AT THE TIME OF RELEASE. NO ADDITIONAL INFO REGARDING THE CAUSE OF DEATH, OR PUMP FUNCTION IS AVAILABLE AT THIS TIME. 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

    THE PT'S SPOUSE REPORTED THAT THE PT PASSED AWAY WHILE ON INSULIN PUMP THERAPY. NO ADDITIONAL INFO REGARDING THE CAUSE OF DEATH, OR PUMP FUNCTION IS AVAILABLE AT THIS TIME.

    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