BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23092368 · Received September 18, 2025

    Report

    Report Number
    3019004087-2025-03057
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 18, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Adverse Event
    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 THE PATIENT REPORTED EXPERIENCING HYPOGLYCEMIA WITH A BLOOD GLUCOSE (BG) LEVEL OF 43 MG/DL DURING THE NIGHT. THE PATIENT REPORTED SYMPTOMS OF SHAKINESS WHEN TREATING THE LOW. THE EVENT WAS CORRECTED WITH SODA, AND BG SUBSEQUENTLY REBOUNDED TO A HIGH LEVEL DUE TO OVERTREATMENT. NO OUTSIDE ASSISTANCE OR MEDICAL INTERVENTION WAS REQUIRED. NO HOSPITALIZATION OCCURRED AND NO LONG-TERM HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270236 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female FREESTYLE LIBRE 3+