BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23600740 · Received November 19, 2025

    Report

    Report Number
    3019004087-2025-08700
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 4, 2024
    Report Date
    November 19, 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

    THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 AT APPROXIMATELY 4:45 PM PST, THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE LEVELS FOLLOWING A SUPPLY AND INFUSION SITE CHANGE EARLIER THAT MORNING. BLOOD GLUCOSE WAS STABLE THROUGHOUT THE DAY UNTIL AFTER DINNER (BLT SANDWICH) APPROXIMATELY 1 HOUR AND 45 MINUTES PRIOR TO THE CALL. THE PATIENT ANNOUNCED THE MEAL AT THE TIME OF EATING. REPORTED BLOOD GLUCOSE RANGED BETWEEN 200¿318 MG/DL FOR ABOUT 1.25 HOURS, WITH THE HIGHEST READING AT 318 MG/DL. THE PATIENT ATTEMPTED A MEAL ANNOUNCEMENT AS A CORRECTION, WHICH THE AGENT ADVISED AGAINST AND PROVIDED EDUCATION ON PROPER CORRECTION METHODS. NO KETONE TESTING WAS PERFORMED, AND NO BACKUP THERAPY OR PROFESSIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT REPORTED NO IMMEDIATE HEALTH EFFECTS (E.G., DIZZINESS, DKA). AGENT ADVISED MONITORING BLOOD GLUCOSE AND TO CALL BACK IF LEVELS REMAINED AT OR ABOVE 300 MG/DL FOR FURTHER TROUBLESHOOTING. PATIENT UNDERSTOOD AND AGREED. CASE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468023 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown