BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23154667 · Received September 26, 2025

    Report

    Report Number
    3019004087-2025-03624
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 26, 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, IT WAS REPORTED THAT THE USER¿S ILET WAS LEAKING INSULIN ON (B)(6) 2025. THE USER SWITCHED TO BACKUP THERAPY AND ADMINISTERED 15 UNITS OF FAST-ACTING INSULIN AT 2:46 PM CST. A MANUAL FINGERSTICK SHOWED BLOOD GLUCOSE (BG) AT 422 MG/DL, WHILE THE DEXCOM G7 DISPLAYED ¿HIGH.¿ THE USER CHANGED OUT SUPPLIES TWICE EARLIER IN THE DAY WITHOUT RESOLUTION. AFTER SWITCHING CARTRIDGE, CONNECTOR, AND TUBING, INSULIN DELIVERY RESUMED. NO EXTERNAL ASSISTANCE OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279114 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

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