BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22938427 · Received September 2, 2025

    Report

    Report Number
    3019004087-2025-01857
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 2, 2025
    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

    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

    ON (B)(6) 2025, THE USER REPORTED RUNNING HIGH WITH A BLOOD GLUCOSE (BG) LEVEL OF 380 MG/DL, NOT OUT OF RANGE FOR MORE THAN 90 MINUTES. WHEN REMOVING THE CARTRIDGE DURING A SUPPLY CHANGE, THEY NOTICED AN AIR BUBBLE PRESENT. THE USER CONFIRMED NO OCCLUSION ALERT HAD OCCURRED, AND PUMP REPORTS SHOWED INSULIN DELIVERY WAS NOT INTERRUPTED. THE USER HAD ALREADY COMPLETED A SUPPLY CHANGE BEFORE CONTACTING SUPPORT. THE AGENT ADVISED MONITORING BG FOR 90 MINUTES. DURING A FOLLOW-UP CALL, THE USER CONFIRMED BG WAS TRENDING DOWN, AND NO FURTHER ASSISTANCE WAS REQUIRED. THE ILET ALERTED FOR HIGH BLOOD GLUCOSE. NO MEDICAL INTERVENTION WAS REQUIRED. THE USER REPORTED SYMPTOMS OF THIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245311 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXCOM G7 CONTINUOUS GLUCOSE MONITOR