BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 14520090 · Received May 26, 2022

    Report

    Report Number
    3004464228-2022-08689
    Event Type
    Death
    Date Received
    May 26, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 17, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385081140003
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY WHILE POSSIBLY USING THE PRODUCT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION REPORTED BY A CORONER'S OFFICE THAT A PATIENT'S DEATH MAY HAVE BEEN RELATED TO THE PRODUCT. BASED ON THE METHOD OF WHICH THIS INFORMATION WAS OBTAINED, NO FURTHER DETAILS CAN BE COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604584 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A 10385081140003

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Death