BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24534747 · Received March 6, 2026

    Report

    Report Number
    3019004087-2026-35803
    Event Type
    Death
    Date Received
    March 6, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 9, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER DEATH OCCURRED FOLLOWING RECENT INITIATION OF ILET THERAPY. DEVICE LOGS DOCUMENT MULTIPLE MEAL ANNOUNCEMENTS AND AN UNPROMPTED ¿FILL TUBING ONLY¿ ACTION ON (B)(6) 2026, FOLLOWED ON (B)(6) 2026 BY CGM-RELATED ALERTS, ENTRY INTO BG RUN MODE, AND SUSPENSION OF INSULIN DELIVERY DUE TO LACK OF ENTERED BG VALUE. NO USER INTERACTION WAS LOGGED AFTER 4:14 PM ON (B)(6) 2026. THE USER WAS REPORTED TO HAVE SIGNIFICANT UNDERLYING MEDICAL CONDITIONS, INCLUDING DIALYSIS TREATMENT. AT THIS TIME, CLINICAL DETAILS SURROUNDING THE CAUSE OF DEATH ARE LIMITED, AND THE FULL ENGINEERING FAILURE INVESTIGATION HAS NOT YET BEEN COMPLETED. BASED ON CURRENTLY AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE CONFIRMED, AND THE EVENT REMAINS CAUSE NOT ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, INCLUDING COMPLETION OF ENGINEERING ANALYSIS OR RECEIPT OF ADDITIONAL CLINICAL DETAILS, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP INFORMATION WAS OBTAINED THROUGH DEVICE DATA REVIEW FOR THE REPORTED EVENT. THE ENGINEERING LOGS AVAILABLE WERE LAST SYNCED ON (B)(6) 2026 AT 07:36 AM, AND THEREFORE DO NOT INCLUDE DATA BEYOND THAT TIME. THE DEVICE WAS INITIALLY SET UP ON (B)(6) 2026 AT APPROXIMATELY 12:51 PM. REVIEW OF AVAILABLE ENGINEERING LOGS IDENTIFIED NO MALFUNCTION ALERTS, NO FACTORY RESETS, AND NO MOTOR ERRORS INDICATIVE OF INACCURATE INSULIN DELIVERY RELATIVE TO DELIVERY REQUESTS. A DEXCOM G7 SENSOR WAS IN USE AT THE TIME OF THE EVENT. ANALYSIS OF CGM AND INSULIN DELIVERY DATA DEMONSTRATED THAT THE ILET RESPONDED APPROPRIATELY TO GLUCOSE VALUES, WITH ALERTS TRIGGERING AS INTENDED AND INSULIN DOSING OCCURRING AT REGULAR INTERVALS. PRIOR TO THE LAST AVAILABLE LOG SYNC, DEVICE ACTIVITY INCLUDED MULTIPLE MEAL ANNOUNCEMENTS AND AN UNPROMPTED ¿FILL TUBING ONLY¿ ACTION, FOLLOWED BY CGM-RELATED ALERTS, ENTRY INTO BG RUN MODE, AND SUBSEQUENT SUSPENSION OF INSULIN DELIVERY DUE TO LACK OF ENTERED BG VALUE. NO USER INTERACTION WAS RECORDED AFTER 4:14 PM ON (B)(6) 2026. THE USER WAS REPORTED TO HAVE SIGNIFICANT UNDERLYING MEDICAL CONDITIONS, INCLUDING DIALYSIS TREATMENT. BASED ON THE AVAILABLE INFORMATION, NO DEVICE MALFUNCTION WAS IDENTIFIED. THE CAUSE OF DEATH REMAINS UNCONFIRMED, AND A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    ON 04-FEB-2026 IT WAS REPORTED THAT ON (B)(6) 2026 THE USER EXPERIENCED AN ADVERSE EVENT AND SUBSEQUENTLY PASSED AWAY. THE USER HAD BEEN ON ILET THERAPY WITHIN 24 HOURS OF DEATH. THE CAUSE OF DEATH HAS NOT BEEN CONFIRMED, AND NO ADDITIONAL MEDICAL DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT USING THE ILET EXPERIENCED AN EXTENDED HYPOGLYCEMIC EVENT FOLLOWING INITIAL HIGH GLUCOSE, MULTIPLE MEAL ANNOUNCEMENTS, A SUPPLY CHANGE, AND AN UNPROMPTED FILL TUBING ONLY ACTION, AND LATER EXPERIENCED DOSING CESSATION WHEN SENSOR READINGS FAILED AND NO BG VALUE WAS ENTERED. SYMPTOMS INCLUDED UNSPECIFIED CLINICAL EFFECTS DUE TO INSUFFICIENT INFORMATION. OUTCOMES INCLUDED THE PATIENT¿S DEATH. INVESTIGATION INCLUDED COMMUNICATION AND INTERVIEWS WITH THE PATIENT¿S CAREGIVERS AND ANALYSIS OF INFORMATION PROVIDED BY THIRD PARTIES. INVESTIGATION OF THIS CASE REVEALED NO FINDINGS AND INSUFFICIENT INFORMATION REGARDING ANY DEVICE PROBLEM OR SPECIFIC DEVICE COMPONENT INVOLVEMENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS NOT ESTABLISHED. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110534 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Death DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.