BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22932219 · Received September 2, 2025

    Report

    Report Number
    3019004087-2025-01788
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 1, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    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 PROLONGED ELEVATED BLOOD GLUCOSE LEVELS AND SKIN IRRITATION AT INFUSION SITES. THE USER HAS A HISTORY OF ALLERGIES AND WAS USING A SPECIFIC SKIN PREP PRODUCT, WHICH APPEARED TO CAUSE IRRITATION, REDNESS, AND SITE REACTION. THE USER NOTED NO BENT NEEDLE OR BLEEDING AND CONFIRMED THAT ALL INSERTIONS WERE ON THE STOMACH OR ARMS. THE ISSUE PERSISTED THROUGH MULTIPLE SITE CHANGES USING SUPPLIES FROM THE SAME BOX. REPLACEMENT SUPPLIES WERE SENT. THE HIGHEST BG REPORTED WAS 400 MG/DL, AND THE ELEVATED LEVELS LASTED FOR APPROXIMATELY 10 HOURS. THE ILET ALERTED THE USER, AND BG LEVELS WERE EVENTUALLY CORRECTED THROUGH A SUPPLY CHANGE. NO MEDICAL INTERVENTION OR EXTERNAL ASSISTANCE WAS REQUIRED, AND NO SYMPTOMS BEYOND THE SITE IRRITATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223116 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other CONVATEC CONTACT DETACH (23", 6MM)