BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23651063 · Received November 25, 2025

    Report

    Report Number
    3019004087-2025-09537
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    August 15, 2024
    Report Date
    November 25, 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

    IT WAS REPORTED THAT A USER EXPERIENCED HYPOGLYCEMIA WHILE USING AN ILET A103101, REQUESTED ENGINEERING LOGS FOR REVIEW, AND SUBSEQUENTLY PERFORMED A FACTORY RESET AFTER EPISODES OF INSULIN DELIVERY IN THE LATE AFTERNOON TO EVENING; TROUBLESHOOTING AND EDUCATION WERE COMPLETED WITH THE USER. SYMPTOMS INCLUDED LOW GLUCOSE WITH A REPORTED NADIR OF 39 MG/DL, LOSS OF CONSCIOUSNESS, AND SEIZURE. OUTCOMES INCLUDED USE OF ORAL CARBOHYDRATES AND ADMINISTRATION OF GLUCAGON, WITH ASSISTANCE FROM A CAREGIVER. INVESTIGATION INCLUDED REVIEW OF UPLOADED DEVICE DATA AND USER-PROVIDED HISTORY. INVESTIGATION OF THIS CASE REVEALED THE CAUSE OF THE HYPOGLYCEMIA WAS UNCLEAR. IT WAS CONCLUDED THAT NO DEVICE MALFUNCTION COULD BE CONFIRMED AND THE EVENT WAS ATTRIBUTED TO HYPOGLYCEMIA OF UNCLEAR CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947063 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown