BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4961364 · Received July 30, 2015

    Report

    Report Number
    3004464228-2015-00377
    Event Type
    Death
    Date Received
    July 30, 2015
    Date of Event
    June 13, 2015
    Report Date
    July 1, 2015
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. NO PRODUCT MALFUNCTION WAS ALLEGED. NO QUALIFICATION RECORDS WERE REVIEWED; NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE PT'S HUSBAND REPORTED HIS WIFE HAD PASSED AWAY ON (B)(6) 2015 DUE TO COMPLICATION FROM HER PANCREATIC CANCER AND THAT IT WAS NOT DIABETES RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495819 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death