BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23032592 · Received September 11, 2025

    Report

    Report Number
    3019004087-2025-02637
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    August 16, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A CUSTOMER SUPPORT AGENT THAT THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) UP TO 260 MG/DL AFTER RECONNECTING TO THE ILET FOLLOWING A FACTORY RESET. THE ILET WAS RELEARNING THE USER¿S INSULIN NEEDS, AND BG WAS TRENDING DOWN TO 243 MG/DL AT THE TIME OF THE CALL. NO FURTHER ASSISTANCE WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573472 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXCOM G7 CONTINUOUS GLUCOSE MONITOR