BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24133195 · Received January 21, 2026

    Report

    Report Number
    3019004087-2026-23278
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 6, 2025
    Report Date
    January 21, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER EXPERIENCED SEVERE HYPOGLYCEMIA RESULTING IN LOSS OF CONSCIOUSNESS AND HOSPITALIZATION WHILE RECEIVING AUTOMATED INSULIN DELIVERY WITH THE ILET. THIS SITUATION CAN RESULT IN LIFE-THREATENING HYPOGLYCEMIA REQUIRING EMERGENCY MEDICAL INTERVENTION AND HOSPITALIZATION AND IS CONSISTENT WITH THE REPORTED LOSS OF CONSCIOUSNESS, EMERGENCY MEDICAL SERVICES TRANSPORT, AND INPATIENT ADMISSION. AVAILABLE INFORMATION INDICATES THE EVENT OCCURRED SHORTLY AFTER REINITIATION OF ILET THERAPY FOLLOWING A PROLONGED PERIOD OFF THE DEVICE, WITH LIMITED AVAILABLE DEVICE DATA DUE TO LACK OF SYNCHRONIZATION AND ABSENCE OF A COMPATIBLE PHONE. ENGINEERING LOGS AVAILABLE FOR REVIEW DID NOT CONTAIN DATA SURROUNDING THE EVENT TIMEFRAME AND DID NOT RECORD ANY MALFUNCTION ALERTS. CLINICAL INFORMATION SUGGESTS THE EVENT MAY HAVE BEEN INFLUENCED BY CLINICAL OR USE-RELATED FACTORS, INCLUDING RECENT THERAPY RESTART, ALTERED INSULIN SENSITIVITY, RECENT SUPPLY CHANGES, OR POSSIBLE ADMINISTRATION OF EXOGENOUS INSULIN OUTSIDE OF THE ILET, AS SUGGESTED BY THE HEALTHCARE PROVIDER. DUE TO INCOMPLETE EVENT TIMING, LIMITED DEVICE DATA, AND LACK OF CORROBORATING CLINICAL DETAILS, THE PRECISE CAUSE OF THE HYPOGLYCEMIC EVENT COULD NOT BE DEFINITIVELY DETERMINED, AND NO DEVICE MALFUNCTION WAS IDENTIFIED BASED ON THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 31-DEC-2025, IT WAS REPORTED THAT IN (B)(6) 2025 THE USER EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE (BG) LEVELS REPORTED AS LOW AS 12 MG/DL FOLLOWING A PERIOD OF ELEVATED BLOOD GLUCOSE EARLIER IN THE DAY. THE USER LOST CONSCIOUSNESS, AND EMERGENCY MEDICAL SERVICES WERE CALLED BY A FAMILY MEMBER. THE USER WAS TRANSPORTED TO THE HOSPITAL, WHERE THE USER WAS ADMITTED, TREATED FOR HYPOGLYCEMIA, AND DISCHARGED ON (B)(6) 2025. NO LONG-TERM HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200766 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.