BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24140999 · Received January 21, 2026

    Report

    Report Number
    3019004087-2026-23474
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 21, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    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 PATIENT USING THE ILET EXPERIENCED HYPERGLYCEMIA WITH FINGERSTICK READINGS OF 285 MG/DL TRENDING UPWARD OVERNIGHT AND 299 MG/DL AFTER AN INFUSION SITE CHANGE; THE CONTACT DETACH STEEL INFUSION SET WITH LOT 6013996 WAS CHANGED AND INSULIN DELIVERY WAS RESUMED WITH GUIDANCE. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HOSPITALIZATION AND NO DEVICE ALARMS. INVESTIGATION INCLUDED TELEPHONE TROUBLESHOOTING AND EDUCATION THAT LED TO AN INFUSION SITE REPLACEMENT AND MONITORING FOR DOWNWARD GLUCOSE TREND. INVESTIGATION OF THIS CASE REVEALED THAT THE HYPERGLYCEMIA OCCURRED WITH AN UNCLEAR CAUSE, AND THE DEVICE FUNCTIONED WITHOUT ALARMS, WITH RESOLUTION STEPS FOCUSED ON INFUSION SITE INTEGRITY AND CONTINUED OBSERVATION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. 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
    202806 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other