BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23058340 · Received September 15, 2025

    Report

    Report Number
    3019004087-2025-02724
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 15, 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 THAT THE USER EXPERIENCED FLUCTUATING BLOOD GLUCOSE (BG), WITH LOWS OF 53 MG/DL AND HIGHS OF 376 MG/DL. THE USER¿S CAREGIVER STATED THEY HAD OCCASIONALLY ALTERED CARB REPORTING AND PERFORMED ¿GHOST ALERTS¿ TO RECEIVE INSULIN, WHICH LED TO MALADAPTATION. THE USER TREATED LOWS WITH JUICE AND BG WAS CORRECTED BY THE ILET CORRECTIVE ALGORITHM. NO SYMPTOMS, EXTERNAL ASSISTANCE, OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397685 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FREESTYLE LIBRE 3+.