BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23167885 · Received September 29, 2025

    Report

    Report Number
    3019004087-2025-03761
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 31, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    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 THAT A BETA BIONICS ILET USER EXPERIENCED A HYPERGLYCEMIC EPISODE WITH A PEAK BLOOD GLUCOSE VALUE OF 400 MG/DL AFTER THE DEVICE WAS NOT DELIVERING INSULIN. THE USER MANAGED THE EVENT BY REVERTING TO MULTIPLE DAILY INJECTIONS UNTIL INSULIN DELIVERY WAS CONFIRMED TO RESUME. NO OUTSIDE MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773314 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

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