BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 POD

    MDR report key: 19954001 · Received August 9, 2024

    Report

    Report Number
    3004464228-2024-31354
    Event Type
    Death
    Date Received
    August 9, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 9, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    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 PATIENT'S PASSING. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED FROM AN UNCONFIRMED CUSTOMER ALLEGING, " FAMILY FRIEND FEW WEEKS AGO THAT HAD DIED OF AN OVERDOSE OF INSULIN FROM OMNIPOD." THREE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER WERE COMPLETED BUT NO NEW INFORMATION BECAME AVAILABLE. IF NEW INFORMATION BECOMES AVAILABLE WE WILL REOPEN AND SUPPLEMENT THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462367 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Death