BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24319254 · Received February 11, 2026

    Report

    Report Number
    3019004087-2026-28997
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    February 1, 2026
    Report Date
    February 11, 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 THE USER EXPERIENCED HYPERGLYCEMIA WHILE USING THE ILET SYSTEM, WITH BLOOD GLUCOSE VALUES TRENDING UPWARD OVERNIGHT AND REACHING 398 MG/DL BY SENSOR AND 420 MG/DL BY FINGERSTICK; THE USER HAD RECENTLY CHANGED SUPPLIES AND SUBSEQUENTLY CHANGED THE INFUSION SITE (CONTACT DETACH STEEL, LOT 6012208) AND RESUMED INSULIN DELIVERY WITH GUIDANCE. SYMPTOMS INCLUDED HIGH BLOOD GLUCOSE. OUTCOMES INCLUDED ON-DEVICE TROUBLESHOOTING AND EDUCATION, WITH INSTRUCTIONS TO MONITOR FOR GLUCOSE DECLINE OVER THE NEXT 90 MINUTES. INVESTIGATION INCLUDED REMOTE TROUBLESHOOTING AND USER-GUIDED INFUSION SITE REPLACEMENT. INVESTIGATION OF THIS CASE REVEALED THAT THE CAUSE OF THE HIGH GLUCOSE WAS UNCLEAR, WITH NO CONFIRMED DEVICE MALFUNCTION IDENTIFIED AND NO DEVICE COMPONENT FAILURE OBSERVED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNDETERMINED. 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
    375797 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other