BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23526504 · Received November 11, 2025

    Report

    Report Number
    3019004087-2025-07578
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER RECEIVED AN INSULIN OCCLUSION ALERT ON THE ILET SYSTEM AFTER A SUPPLY CHANGE, AND TROUBLESHOOTING CONFIRMED THE MOTOR FUNCTION WAS NORMAL WHILE AN INFUSION SITE ISSUE WAS SUSPECTED; THE USER PERFORMED A DRY RUN, THEN CHANGED THE INFUSION SET AND SUPPLIES, WHICH RESOLVED THE OCCLUSION. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE OF 171 MG/DL WITHOUT REPORTED CLINICAL SEQUELAE. OUTCOMES INCLUDED THE NEED FOR DEVICE INTERVENTION AND USER GUIDANCE, WITH RESTORATION OF THERAPY AFTER THE INFUSION SET AND SUPPLY CHANGE. INVESTIGATION INCLUDED TECHNICAL SUPPORT TROUBLESHOOTING AND USER-PERFORMED FUNCTIONAL CHECKS. INVESTIGATION OF THIS CASE REVEALED AN INFUSION SITE ISSUE CONSISTENT WITH AN OCCLUSION THAT RESOLVED AFTER CHANGING TO A NEW INFUSION SITE (CONTACT DETACH STEEL, LOT 6011604) AND SUPPLIES WHILE THE MOTOR OPERATED AS INTENDED. IT WAS CONCLUDED THAT THE EVENT WAS RELATED TO AN INFUSION PATHWAY OBSTRUCTION AT THE SITE, WITH THE DEVICE FUNCTIONING AS DESIGNED AFTER SUPPLY AND SITE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545537 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown CONVATEC CONTACT DETACH (23", 6MM)