BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 17503660 · Received August 10, 2023

    Report

    Report Number
    3004464228-2023-20441
    Event Type
    Death
    Date Received
    August 10, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 25, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    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. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION, DIABETIC KETOACIDOSIS AND DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIED WHILE IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENTS POD WAS REMOVED ONCE THEY GOT TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH DKA AND PNEUMONIA. THE PATIENT HAD BEEN IN THE INTENSIVE CARE UNIT (ICU) FOR 4 DAYS AND THEN WAS TRANSFERRED TO THE ONCOLOGY DEPARTMENT. THE PATIENT HAD PASSED AWAY ON THE 11TH DAY IN THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED AS TO THIS EVENT. IT SHOULD BE NOTED THE PATIENT SUFFERED FROM STAGE 4 CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851478 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death