BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS - TA000036-001

    MDR report key: 22856618 · Received August 20, 2025

    Report

    Report Number
    3019004087-2025-01181
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 20, 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 BLUETOOTH CONNECTIVITY ISSUES BETWEEN THE ILET AND DEXCOM G7 SENSOR. AFTER TROUBLESHOOTING, THE SENSOR RECONNECTED, AND THE USER CONFIRMED A HIGH BG OF 425 MG/DL, VERIFIED BY FINGERSTICK AND CALIBRATION. BLOOD GLUCOSE WAS CORRECTED AFTER RECONNECTION. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403871 ILET BIONIC PANCREAS - TA000036-001 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

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