BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 19799654 · Received July 22, 2024

    Report

    Report Number
    3004464228-2024-27764
    Event Type
    Death
    Date Received
    July 22, 2024
    Date of Event
    June 24, 2016
    Report Date
    July 22, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385081140003
    PMA / PMN Number
    K211575
    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

    A SOCIAL MEDIA POST REPORTED: "OMNIPOD KILLED MY SON BACK IN 2016". THE SOCIAL MEDIA POST DID NOT REPORT ANY DETAILS, INCLUDING PATIENT OR DEVICE INFORMATION. CONTACT DETAILS FOR THE REPORTER WERE ALSO NOT INCLUDED IN THE INITIAL REPORT. INSULET RESPONDED TO THE SOCIAL MEDIA POST REQUESTING FURTHER INFORMATION, HOWEVER AT THE TIME OF THIS REPORT ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED. THIS CASE WILL BE REASSESSED IF NEW INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472642 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A 10385081140003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death