BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22986609 · Received September 5, 2025

    Report

    Report Number
    3019004087-2025-02216
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    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 (B)(6) 2025, THE PATIENT REPORTED HIGH BLOOD GLUCOSE (BG) AND RECEIVED A ¿CONNECT CGM OR ENTER BG¿ ALERT. THE AGENT GUIDED THE PATIENT THROUGH RESTARTING THE PUMP AND TOGGLING FROM G6 TO G7, SUCCESSFULLY COMPLETING PAIRING (CODE: 4614). A FINGERSTICK BLOOD GLUCOSE (BG) READING WAS 390 MG/DL, WHICH THE AGENT HAD THE PATIENT ENTER INTO THE PUMP FOR DOSING. THE AGENT PLANNED A FOLLOW-UP CALL IN 30 MINUTES TO CONFIRM SENSOR CONNECTION. ON (B)(6) 2025, THE AGENT FOLLOWED UP AND CONFIRMED THE SENSOR HAD RECONNECTED. BG WAS 290 MG/DL AND TRENDING DOWNWARD. THE AGENT ADVISED THAT IT MAY TAKE 1¿2 HOURS FOR BG TO RETURN FULLY TO RANGE. THE PATIENT UNDERSTOOD. THE BG WAS CORRECTED BY CONNECTING TO CGM. THE PATIENT REPORTED OF BEING TIRED DURING THE EVENT. NO MEDICAL INTERVENTION REPORTED AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237600 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Other DEXCOM G7 CGM.