BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22935404 · Received September 2, 2025

    Report

    Report Number
    3019004087-2025-01816
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 1, 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 (B)(6) 2025, PATIENT¿S CONTACT REPORTED A LEAKING CARTRIDGE INSTALLED THE PREVIOUS NIGHT, CONTRIBUTING TO HIGH BLOOD GLUCOSE (BG) WHICH IS 400 MG/DL AT THE TIME OF CALL. AGENT WALKED THEM THROUGH DRYING THE INSULIN CHAMBER, REVIEWED PROPER CARTRIDGE ATTACHMENT, AND COMPLETED A FULL SUPPLY CHANGE. INSULIN DELIVERY WAS RESUMED. BG HAS BEEN HIGH SINCE LAST NIGHT. THE BG WAS CORRECTED BY CHANGING ALL SUPPLIES AND ALLOWING TIME FOR CORRECTIONS. NO REPLACEMENT SUPPLIES NEEDED AT THIS TIME; THE PATIENT DECLINED FOLLOW-UP AND WILL REACH OUT IF CONCERNS ARISE. THE PATIENT EXPERIENCED HEADACHE AND THIRSTINESS DURING THE EVENT. NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890398 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female INSULIN CARTRIDGE.