BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23063615 · Received September 16, 2025

    Report

    Report Number
    3019004087-2025-02794
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 16, 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, THE USER REPORTED EXPERIENCING LOW BLOOD GLUCOSE (BG) EVENTS AFTER MEALS SINCE PERFORMING A FULL RESET OF THE ILET. THE AGENT EXPLAINED THE ADAPTATION AND MEAL ANNOUNCEMENT PROCESSES. THE USER NOTED THAT TREATING WITH 15 GRAMS OF CARBOHYDRATES, AS RECOMMENDED BY THEIR HEALTHCARE PROVIDER (HCP), CAUSED OVERCORRECTION, AND ADMITTED THEY HAD NOT YET DISCUSSED MODIFYING THEIR ACTION PLAN WITH THE HCP. REPORTED SYMPTOMS INCLUDED FEELING WOOZY AND EXPERIENCING BALANCE ISSUES, THOUGH BG EVENTUALLY STABILIZED. THE USER ASKED ABOUT ADJUSTING INSULIN DELIVERY DURING MEALS, AND THE AGENT REITERATED THAT THE ILET ALGORITHM ADAPTS OVER TIME. THE AGENT ALSO NOTED EXTERNAL MEDICAL FACTORS COULD AFFECT BG VARIABILITY. THE USER WAS ADVISED TO FOLLOW UP WITH THEIR TRAINER AND HCP FOR FURTHER GUIDANCE. THE LOWEST BG WAS 50 MG/DL, NOT OUT OF RANGE FOR MORE THAN 90 MINUTES, CORRECTED WITH 15 GRAMS OF FAST-ACTING CARBOHYDRATES. THE ILET ALERTED FOR THE LOW, AND NO OUTSIDE ASSISTANCE OR MEDICAL INTERVENTION WAS REQUIRED AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2674041 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female