BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22964523 · Received September 4, 2025

    Report

    Report Number
    3019004087-2025-02073
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 4, 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

    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 08/08/2025, THE BETA BIONICS ILET USER CONTACTED SUPPORT DUE TO RECEIVING ALERT 41 - ABSOLUTE RANGE ERROR (FALSE HOMING) DURING A SUPPLY CHANGE. THE ISSUE OCCURRED AFTER REMOVING THE CARTRIDGE BEFORE PERFORMING A REWIND. THE USER ATTEMPTED TO RESTART THE DEVICE BUT WAS UNABLE TO INITIATE A REWIND AND CONTINUED TO RECEIVE RESTART ALERTS. BACKUP THERAPY WAS USED. A HIGH BLOOD GLUCOSE (BG) LEVEL OF 317 MG/DL WAS RECORDED BUT WAS CORRECTED USING MULTIPLE DAILY INJECTIONS (MDI). THE EVENT DID NOT PERSIST FOR MORE THAN 90 MINUTES, AND NO SYMPTOMS WERE REPORTED. THE SYSTEM DID NOT ALERT THE USER, AND NO EXTERNAL ASSISTANCE OR MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE WAS RETURNED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991755 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other DEXCOM G7 CGM