BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24683721 · Received March 25, 2026

    Report

    Report Number
    3019004087-2026-39558
    Event Type
    Death
    Date Received
    March 25, 2026
    Date of Event
    January 23, 2026
    Report Date
    March 24, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER DIED ON (B)(6) 2026 WHILE USING THE ILET. ENGINEERING LOG REVIEW INDICATED THE ILET WAS FUNCTIONING AS INTENDED, WITH INSULIN DELIVERY REQUESTS AND ALERTS GENERATED APPROPRIATELY AND NO DEVICE MALFUNCTION IDENTIFIED. DEVICE DATA SHOWED ROUTINE USE OF THE DEVICE ON THE REPORTED DATE, INCLUDING A SUPPLY CHANGE, MEAL ANNOUNCEMENTS, AND GLUCOSE VALUES THAT WERE IN RANGE FOR MOST OF THE DAY UNTIL CGM SENSOR FAILURE AT 6:57 PM. THE ILET CONTINUED DOSING INSULIN IN BG-RUN MODE UNTIL DOSING STOPPED THE FOLLOWING DAY DUE TO LACK OF BG OR CGM ENTRY. BASED ON THE AVAILABLE DEVICE DATA, IT IS UNLIKELY THAT THE USER¿S DEATH WAS RELATED TO DIABETES OR ILET USE; HOWEVER, WITHOUT ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF DEATH, THIS CANNOT BE DEFINITIVELY CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 23-FEB-2026 IT WAS REPORTED THAT ON (B)(6) 2026 THE USER DIED. NO TREATMENT DETAILS WERE REPORTED. THE OUTCOME WAS DEATH. FOLLOW UP ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749010 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Death DEXCOM G7 CGM.