BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22918220 · Received August 28, 2025

    Report

    Report Number
    3019004087-2025-01615
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 28, 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 01-AUG-2025, THE USER REPORTED THAT ON (B)(6) 2025, DURING THEIR FIRST DAY OF ILET USE, THEY EXPERIENCED A LOW BLOOD GLUCOSE (BG) EVENT. THE LOWEST RECORDED BG WAS 40 MG/DL. THE EVENT WAS CORRECTED WITH GLUCOSE TABLETS, AND BG RETURNED TO RANGE. THE DEVICE PROVIDED A LOW BG ALERT. NO SYMPTOMS WERE REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235830 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