BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 11888575 · Received May 26, 2021

    Report

    Report Number
    3004464228-2021-08237
    Event Type
    Death
    Date Received
    May 26, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 12, 2021
    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 · 1

    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 MEDICAL INTERVENTION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION DUE TO HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS DROPPED TO 31 MG/DL WHILE WEARING THE POD FOR LESS THAN ONE HOUR. SYMPTOMS REPORTED INCLUDE THAT PATIENT WAS "THRASHING AROUND AND BEHAVING ERRATICALLY"; THE PATIENT ALSO TORE OFF THE POD WHILE THIS EVENT WAS OCCURRING. A CARDIAC EVENT ALSO OCCURRED PRIOR TO BEING TAKEN TO HOSPITAL. PATIENT WAS HOSPITALIZED AND A MULTITUDE OF OTHER MEDICAL ISSUES WERE REPORTED, INCLUDING BUT NOT LIMITED TO: CONGESTIVE HEART FAILURE, ACUTE KIDNEY FAILURE, SEVERE DIABETIC NEUROPATHY, AND SLEEP APNEA. PATIENT REMAINED IN 3 HOSPITALS IN TOTAL, OVER THE COURSE OF 2+ MONTHS. AFTER 61 DAYS, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783376 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R