BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23618797 · Received November 21, 2025

    Report

    Report Number
    3019004087-2025-08953
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    August 4, 2024
    Report Date
    November 21, 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

    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

    IT WAS REPORTED THAT THE PATIENT¿S CARETAKER STATED THE PATIENT¿S BLOOD GLUCOSE HAD DROPPED TO 64 MG/DL. THE CARETAKER ANNOUNCED A ¿LESS THAN¿ MEAL WHILE THE PATIENT¿S BLOOD GLUCOSE WAS IN THE 60S. THE PATIENT¿S BLOOD GLUCOSE INITIALLY ROSE TO THE LOW 80S AFTER EATING BUT DROPPED BACK INTO THE 60S FOLLOWING THE MEAL ANNOUNCEMENT. THE CARETAKER TREATED THE LOW WITH TWO JUICE BOXES AND A PEANUT BUTTER CRACKER, AFTER WHICH THE PATIENT¿S BLOOD GLUCOSE INCREASED TO 74 MG/DL AND CONTINUED TO RISE GRADUALLY. THE CARETAKER WAS ADVISED TO TREAT LOW BLOOD GLUCOSE WITH 15 GRAMS OF FAST-ACTING CARBOHYDRATES EVERY 15 MINUTES AND TO AVOID ANNOUNCING MEALS OR CORRECTIONS WHILE THE PATIENT¿S BLOOD GLUCOSE WAS LOW, AS THIS COULD LEAD TO FURTHER DECREASES. THE CARETAKER WAS ALSO ADVISED TO CONTINUE MONITORING THE PATIENT¿S BLOOD GLUCOSE CLOSELY DUE TO THE POSSIBILITY OF OVERCORRECTION FROM MULTIPLE CARBOHYDRATE TREATMENTS. THE CARETAKER ACKNOWLEDGED ALL GUIDANCE, AND NO ADDITIONAL ASSISTANCE WAS NEEDED. THE PATIENT¿S BLOOD GLUCOSE HAD BEEN AFFECTED DURING THIS EVENT, WITH A LOWEST REPORTED VALUE OF 64 MG/DL LASTING APPROXIMATELY ONE HOUR. NO KETONE TESTING WAS PERFORMED, NO STEROID USE WAS REPORTED, AND NO PROFESSIONAL MEDICAL INTERVENTION WAS NEEDED. THE PATIENT ROUTINELY RECEIVES ASSISTANCE FROM A CARETAKER FOR ALL DEVICE AND DIABETES-RELATED CARE. THE PATIENT EXPERIENCED DIFFICULTY THINKING CLEARLY DURING THE EVENT BUT REPORTED NO OTHER IMMEDIATE HEALTH EFFECTS. THE DEVICE HAS NOT BEEN RETURNED. IF IT IS RETURNED, IT WILL BE EVALUATED, AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925856 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown