BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23023116 · Received September 10, 2025

    Report

    Report Number
    3019004087-2025-02564
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 10, 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 A BLOOD GLUCOSE LEVEL OF 60 MG/DL AND TREATED THE LOW BLOOD GLUCOSE BY DRINKING MOUNTAIN DEW. THE USER HAD NO FURTHER QUESTIONS, AND THE CALL ENDED WITHOUT ESCALATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541631 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other