BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23183366 · Received September 30, 2025

    Report

    Report Number
    3019004087-2025-03878
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 30, 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 02-SEP-2025, IT WAS REPORTED THAT A BETA BIONICS ILET USER EXPERIENCED FLUCTUATING BLOOD GLUCOSE WITH A LOWEST REPORTED VALUE OF 40 MG/DL AND A HIGHEST REPORTED VALUE OF 400 MG/DL. THE USER MANAGED THE HYPOGLYCEMIA WITH FAST-ACTING CARBS AND REMAINED CONNECTED TO THE DEVICE AS INSULIN DELIVERY CONTINUED FOR THE HYPERGLYCEMIA. NO OUTSIDE MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837116 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