BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24297155 · Received February 9, 2026

    Report

    Report Number
    3019004087-2026-28147
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 20, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED BEYOND THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYS ASSOCIATED WITH RECENT INTERNAL SYSTEM CHANGES. THE DELAY WAS UNINTENTIONAL AND HAS SINCE BEEN ADDRESSED THROUGH PROCESS AND SYSTEM UPDATES TO PREVENT RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER PERFORMED A SUPPLY CHANGE ON AN ILET PUMP AND INSERTED A NEW INSULIN CARTRIDGE BEFORE EXECUTING THE REQUIRED REWIND, WITH TUBING DISCONNECTED FROM THE BODY DURING INSERTION WITH REPORTED BLOOD GLUCOSE VALUES AROUND 203¿240 MG/DL BEFORE TRENDING DOWN TO 157 MG/DL. AFTER EDUCATION, INSULIN DELIVERY WAS RESUMED AND THE USER RETAINED RECENTLY CHANGED TUBING. INVESTIGATION OF THIS CASE REVEALED NO DEVICE PROBLEM FOUND, A USAGE PROBLEM WAS IDENTIFIED, AND THE SEQUENCE INVOLVED THE PLUNGER COMPONENT AS PART OF THE SUPPLY CHANGE PROCESS, ALIGNING WITH AN IMPROPER OR INCORRECT PROCEDURE. NO CLINICAL SYMPTOMS ASSOCIATED WITH HYPERGLYCEMIA REPORTED. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS FAILURE TO FOLLOW INSTRUCTIONS AND THAT AN UNINTENDED USE ERROR CONTRIBUTED TO THE EVENT. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358815 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown