BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23610623 · Received November 20, 2025

    Report

    Report Number
    3019004087-2025-08849
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED BEYOND THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYS ASSOCIATED WITH RECENT INTERNAL SYSTEM CHANGES. THE DELAY WAS UNINTENTIONAL AND HAS SINCE BEEN ADDRESSED THROUGH PROCESS AND SYSTEM UPDATES TO PREVENT RECURRENCE.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE USER WAS HOSPITALIZED FOR HYPERGLYCEMIA WITH A BG OF 401 MG/DL AFTER EXPERIENCING HIGH READINGS FOR APPROXIMATELY 42 HOURS WHILE USING THE ILET. THE USER WAS TREATED WITH IV FLUIDS AT MASSACHUSETTS GENERAL HOSPITAL AND DISCHARGED THE SAME DAY. THE HEALTHCARE PROVIDER SUSPECTED POSSIBLE INSULIN DEGRADATION OR A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528571 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Hospitalization DEXCOM G7 CGM