BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23106154 · Received September 21, 2025

    Report

    Report Number
    3019004087-2025-03219
    Event Type
    Injury
    Date Received
    September 21, 2025
    Date of Event
    August 23, 2025
    Report Date
    September 21, 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, THE PATIENT REPORTED EXPERIENCING HYPOGLYCEMIA WITH A BLOOD GLUCOSE (BG) LEVEL OF 40 MG/DL AFTER A DINNER MEAL ANNOUNCEMENT. THE LOW WAS ATTRIBUTED TO A MISMATCH BETWEEN THE MEAL ENTRY AND THE ACTUAL CARB LOAD (RIBS WITH BBQ SAUCE AND RICE). THE EVENT WAS CORRECTED WITH THREE GLUCOSE TABLETS, AND BG RETURNED TO RANGE. THE PATIENT DID NOT REQUIRE OUTSIDE ASSISTANCE OR MEDICAL INTERVENTION AND REPORTED NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027348 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other DEXCOM G7 CGM.