BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25136310 · Received May 11, 2026

    Report

    Report Number
    3019004087-2026-46568
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 11, 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 A USER RECEIVED A TEFLON INFUSION SET INSTEAD OF THEIR PREFERRED CD STEEL INFUSION SET AND EXPERIENCED DIFFICULTY DURING INSERTION, INCLUDING THE BLUE APPLICATOR PIECE DETACHING DURING SPRING-LOADING AND ONE INFUSION SITE FAILING TO ADHERE AFTER INSERTION, WITH LOT 6013340 NOTED. NO REPORTED SYMPTOMS OR CLINICAL EFFECTS. OUTCOMES INCLUDED USER EDUCATION, CONFIRMATION OF ADDRESS, AND ARRANGEMENT TO PROVIDE REPLACEMENT CD STEEL INFUSION SETS. INVESTIGATION INCLUDED TROUBLESHOOTING AND EDUCATION WITH VIDEO AND STEP-BY-STEP GUIDANCE. INVESTIGATION OF THIS CASE REVEALED DEPLOYMENT AND ADHESION ISSUES DURING INFUSION SET INSERTION, CONSISTENT WITH AN INCORRECTLY DEPLOYED INFUSION SET AND POTENTIAL APPLICATOR DETACHMENT AFFECTING PLACEMENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER TECHNIQUE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48590 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1