BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22822626 · Received August 16, 2025

    Report

    Report Number
    3019004087-2025-01004
    Event Type
    Injury
    Date Received
    August 16, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 15, 2025
    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

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BETA BIONICS ILET USER CRACKED THEIR ILET A COUPLE DAYS AGO AND EXPERIENCED A HYPERGLYCEMIC EVENT OF 401 MG/DL BLOOD GLUCOSE (BG). THE USER CORRECTED WITH INSULIN SHOTS AND HAD ASSISTANCE FROM HER BOYFRIEND OUT OF KINDNESS. SHE EXPERIENCED EXCESSIVE THIRST AND URINATION FROM THIS EVENT. A REPLACEMENT ILET WAS SHIPPED OVERNIGHT TO THE USER. NO FURTHER HEALTH CONSEQUENCES WERE REPORTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457054 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male