BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23187237 · Received September 30, 2025

    Report

    Report Number
    3019004087-2025-03927
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    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, IT WAS REPORTED THAT THE USER¿S ILET DISPLAYED AN EMPTY CARTRIDGE ALERT DESPITE USE OF A NEW CARTRIDGE. THE USER ATTEMPTED TO PROCEED BUT RECEIVED REPEATED ¿UNABLE TO PROCEED¿ MESSAGES, ALONG WITH A BODY WEIGHT ALERT. AFTER CONFIRMING WEIGHT AND RETRYING, THE ALERT PERSISTED. THE AGENT GUIDED THE USER THROUGH A DRY RUN, WHICH SUCCESSFULLY REACHED 120 UNITS, AND THEN THROUGH A FULL SUPPLY CHANGE. INSULIN DELIVERY RESUMED WITHOUT FURTHER ISSUE. BLOOD GLUCOSE WAS UNAFFECTED. NO SYMPTOMS, EXTERNAL ASSISTANCE, OR MEDICAL INTERVENTION OCCURRED. NO SYMPTOMS, EXTERNAL ASSISTANCE, OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155390 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

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