BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7035158 · Received November 15, 2017

    Report

    Report Number
    3004464228-2017-06270
    Event Type
    Death
    Date Received
    November 15, 2017
    Date of Event
    December 27, 2015
    Report Date
    November 9, 2017
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015. THERE WAS NO FURTHER INFORMATION PROVIDED. THE POD HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811970 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810

    Patients

    Seq Age Sex Outcome Treatment
    1 Death