BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25285263 · Received May 26, 2026

    Report

    Report Number
    3019004087-2026-48446
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 26, 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 THE ILET USER EXPERIENCED MULTIPLE FAILED INFUSION SET INSERTIONS WHEN THE INFUSION SET DETACHED FROM THE APPLICATOR SEVERAL TIMES, RESULTING IN FOUR TO SIX UNUSABLE INFUSION SETS FROM LOT 6011935. SIX REPLACEMENT INFUSION SETS WERE PROVIDED, AND TROUBLESHOOTING AND EDUCATION WERE COMPLETED REGARDING CORRECT INFUSION SET DEPLOYMENT. SYMPTOMS INCLUDED NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED INTERVIEWS AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED NO DEVICE PROBLEM AND IDENTIFIED A USAGE ISSUE RELATED TO AN IMPROPER OR INCORRECT PROCEDURE INVOLVING THE INFUSION SET COMPONENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS FAILURE TO FOLLOW INSTRUCTIONS AND AN UNINTENDED USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74236 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1