BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25221802 · Received May 19, 2026

    Report

    Report Number
    3019004087-2026-47728
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 19, 2026
    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 DURING A SUPPLY CHANGE THE ILET USER INADVERTENTLY PULLED THE INFUSION SET OFF THE APPLICATOR WHILE REMOVING THE NEEDLE GUARD, THEN PREPARED A REPLACEMENT SET BUT INITIALLY FORGOT TO REMOVE THE ADHESIVE BACKING AND LATER HAD A SET THAT DID NOT ADHERE TO THE BODY; THE AGENT PROVIDED EDUCATION TO TWIST THE NEEDLE GUARD BEFORE REMOVAL, AND THE USER ULTIMATELY APPLIED A NEW SET USING SUPPLIES FROM LOT 6011933. THERE WERE NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED. INVESTIGATION OF THIS CASE REVEALED A USAGE PROBLEM WITH AN IMPROPER OR INCORRECT PROCEDURE INVOLVING THE INFUSION SET COMPONENT, WITH NO DEVICE PROBLEM FOUND. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS FAILURE TO FOLLOW INSTRUCTIONS AND AN UNINTENDED USE ERROR THAT CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191541 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1