BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22959523 · Received September 3, 2025

    Report

    Report Number
    3019004087-2025-02031
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    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 8/7/25, THE PATIENT REPORTED OF NOT RECEIVING ALERTS FROM THEIR BIONIC CIRCLE. THE LOWEST BLOOD GLUCOSE (BG) LEVEL REPORTED WAS 45 MG/DL. NOTIFICATIONS AND APPLICATION SETTINGS WERE CONFIRMED ACTIVE. THE AGENT GUIDED PATIENT TO UNFOLLOW THEMSELVES AND DELETE THE APP, THEN REINSTALL AND INVITE THEMSELVES BACK INTO THE CIRCLE. PATIENT WAS ABLE TO SEE READINGS AFTER THIS. AGENT ADVISED TO CALL BACK IF ALERTS DO NOT CONTINUE. NO SYMPTOMS REPORTED BY THE PATIENT DURING THE EVENT. THE PATIENT WAS NOT OUT OF BG RANGE FOR 90+ MINUTES, AND NO MEDICAL INTERVENTION REQUIRED AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255538 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female