BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22999581 · Received September 8, 2025

    Report

    Report Number
    3019004087-2025-02334
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 8, 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

    ON (B)(6) 2025 THE USER REPORTED RECEIVING AN OCCLUSION ALERT FOLLOWING A SUPPLY CHANGE. THE USER¿S BLOOD GLUCOSE WAS 271 MG/DL AT THE TIME OF THE ALERT. A CAREGIVER ASSISTED WITH CHANGING THE INFUSION SET, AFTER WHICH INSULIN DELIVERY RESUMED. THE HYPERGLYCEMIA WAS TREATED THROUGH THE SUPPLY CHANGE TO RESTORE INSULIN DELIVERY. THE USER DID NOT EXPERIENCE SYMPTOMS, DID NOT REQUIRE EMS INTERVENTION, AND REPORTED THAT THE ISSUE RESOLVED WITHOUT LONG-TERM EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441396 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other