BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24431483 · Received February 24, 2026

    Report

    Report Number
    3019004087-2026-32630
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 29, 2025
    Report Date
    February 24, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    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 BEGAN INITIAL ILET TRAINING, USED APPROXIMATELY 80 UNITS OF INSULIN DURING THE SESSION, CHANGED THE CARTRIDGE, AND LATER EXPERIENCED HYPERGLYCEMIA WITH GLUCOSE READINGS IN THE 200¿320 MG/DL RANGE WHILE THE DEVICE CONTINUED DELIVERY AND LEARNED BASAL AND MEAL NEEDS. SYMPTOMS INCLUDED HYPERGLYCEMIA WITHOUT LOSS OF CONSCIOUSNESS, DIZZINESS, KETOACIDOSIS, OR OTHER ACUTE COMPLICATIONS. OUTCOMES INCLUDED NO MEDICAL INTERVENTION, NO BACKUP THERAPY, AND NO KETONE TESTING, WITH GLUCOSE TRENDING DOWN TO 267 MG/DL ON FOLLOW-UP WHILE THE USER HAD ADEQUATE INSULIN ON BOARD. INVESTIGATION INCLUDED TROUBLESHOOTING AND EDUCATION ON ILET ADAPTATION TO BASAL AND MEAL REQUIREMENTS. INVESTIGATION OF THIS CASE REVEALED NO DEVICE MALFUNCTION OR ALARM BEHAVIOR AND THAT THE EVENT WAS CONSISTENT WITH EXPECTED GLYCEMIC VARIABILITY DURING EARLY ADAPTATION WHEN HIGH CARBOHYDRATE INTAKE OCCURRED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487313 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown