BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24721481 · Received March 30, 2026

    Report

    Report Number
    3019004087-2026-39920
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 27, 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 USER DIED FOLLOWING PROLONGED HYPERGLYCEMIA WHILE USING THE ILET. THIS SITUATION CAN RESULT IN ACUTE METABOLIC DECOMPENSATION AND DEATH. ENGINEERING LOG REVIEW INDICATED THE ILET WAS FUNCTIONING AS INTENDED, WITH INSULIN DELIVERY REQUESTS AND ALERTS GENERATED APPROPRIATELY. DEVICE DATA SHOWED PROLONGED HYPERGLYCEMIA BEGINNING WHEN THE INSULIN CARTRIDGE RAN OUT AND WAS NOT REPLACED FOR APPROXIMATELY 15.5 HOURS. AFTER CARTRIDGE REPLACEMENT, HYPERGLYCEMIA PERSISTED, AND AN OCCLUSION ALERT LATER WENT UNACKNOWLEDGED FOR APPROXIMATELY 3 HOURS. A SUBSEQUENT SUPPLY CHANGE WAS LOGGED, BUT LESS THAN 1 UNIT WAS PRIMED, INDICATING THE SUPPLIES MAY NOT HAVE BEEN FULLY REPLACED. HYPERGLYCEMIA CONTINUED UNTIL CGM SIGNAL WAS LOST. BASED ON AVAILABLE INFORMATION, PERSISTENT HYPERGLYCEMIA WAS CONSISTENT WITH INTERRUPTED OR INEFFECTIVE INSULIN DELIVERY DUE TO RUNNING OUT OF INSULIN AND A LIKELY INFUSION-SET OR FLUID-PATHWAY ISSUE. HOWEVER, BECAUSE THE CAUSE OF DEATH IS UNKNOWN, A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE DEFINITIVELY ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 27-FEB-2026 IT WAS REPORTED THAT THE USER WAS EXPERIENCING PROLONGED HYPERGLYCEMIA WITH BLOOD GLUCOSE REPORTED AS ABOVE 400 MG/DL. ON (B)(6) 2026 IT WAS REPORTED THAT THE USER PASSED AWAY. NO TREATMENT WAS REPORTED PRIOR TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199179 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death CGM: FREESTYLE LIBRE 3.