BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS - TA000036-001

    MDR report key: 22854798 · Received August 20, 2025

    Report

    Report Number
    3019004087-2025-01165
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 20, 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

    IT WAS REPORTED THAT A BETA BIONICS ILET USER HAD A HYPERGLYCEMIC EPISODE OF 270 MG/DL BLOOD GLUCOSE (BG) DUE TO EATING A DESSERT AND CHANGING OUT SUPPLIES TOOK A WHILE. THE USER DID NOT ANNOUNCE A FULL MEAL OF CARBS AND WAS TOLD NOT TO ANNOUNCE ON THE FIRST WEEK OF THE ILET. THE AGENT WENT OVER BEST PRACTICES WITH THE USER. THE USER LET THE PUMP CORRECT BG AND DID NOT REQUIRE MEDICAL INTERVENTION OR FURTHER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244330 ILET BIONIC PANCREAS - TA000036-001 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male