BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24723632 · Received March 30, 2026

    Report

    Report Number
    3019004087-2026-39976
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 28, 2026
    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

    THE COMPLAINT INVESTIGATION WAS PERFORMED THROUGH REVIEW OF DEVICE DATA, ENGINEERING LOGS, AND INFORMATION PROVIDED BY THE REPORTER. DEVICE DATA CONFIRMED A HYPOGLYCEMIC EVENT ON (B)(6) 2026; HOWEVER, INSULIN DELIVERY DURING THE PERIOD BEFORE, DURING, AND AFTER THE EVENT WAS BELOW THE USER¿S TYPICAL TOTAL DAILY DOSE. NO MALFUNCTION ALERTS, RESETS, OR ANOMALIES WERE IDENTIFIED IN THE ENGINEERING LOGS, AND THE DEVICE WAS OPERATING IN BG-RUN MODE WITH LIMITED CGM INPUT AT THE TIME OF THE EVENT. AVAILABLE INFORMATION INDICATES THE CGM SENSOR STOPPED PROVIDING READINGS PRIOR TO RESOLUTION OF THE HYPOGLYCEMIC EVENT. ADDITIONALLY, ENTERED BG VALUES DURING PROLONGED SUSPENSION OF INSULIN SUGGEST THE POSSIBILITY OF INSULIN ADMINISTRATION FROM AN EXTERNAL SOURCE, WHICH MAY HAVE CONTRIBUTED TO INCREASED RISK OF HYPOGLYCEMIA. THE USER RECEIVED GLUCAGON AND EMS INTERVENTION FOR A SEVERE HYPOGLYCEMIC EPISODE BUT WAS NOT TRANSPORTED TO THE HOSPITAL. THE USER WAS SUBSEQUENTLY FOUND DECEASED ON (B)(6) 2026. THE REPORTED CAUSE OF DEATH WAS CARDIAC ARREST WITH HYPOGLYCEMIA LISTED. BASED ON AVAILABLE DATA, IT CANNOT BE DETERMINED WHETHER HYPOGLYCEMIA AT THE TIME OF DEATH CONTRIBUTED TO THE CARDIAC EVENT. NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE AVAILABLE EVIDENCE, THE ILET DEVICE WAS PERFORMING AS INTENDED, AND NO DEVICE MALFUNCTION WAS IDENTIFIED. THE USER¿S LONG-STANDING HISTORY OF TYPE 1 DIABETES AND RECURRENT HYPOGLYCEMIA MAY HAVE INCREASED THE RISK OF A CARDIAC EVENT.

    Description of Event or Problem · 0

    ON 26-FEB-2026, THE BETA BIONICS REPRESENTATIVE REPORTED THAT ON (B)(6) 2026, THE USER EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE (BG) LEVELS OF <40 MG/DL FOLLOWING ROUTINE USE OF THE DEVICE. THE USER RECEIVED GLUCAGON FROM A CAREGIVER AND WAS TREATED BY EMS WHERE GLUCOSE LEVELS IMPROVED AND THE USER WAS NOT TRANSPORTED TO THE HOSPITAL. THE USER WAS FOUND DECEASED ON (B)(6) 2026 AND THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST WITH HYPOGLYCEMIA LISTED; NO LONG-TERM HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779705 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Death| O