BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24749775 · Received March 31, 2026

    Report

    Report Number
    3019004087-2026-40195
    Event Type
    Death
    Date Received
    March 31, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 31, 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 WAS REPORTED DECEASED WITH LIMITED INFORMATION AVAILABLE REGARDING THE CIRCUMSTANCES OF DEATH. ENGINEERING LOG REVIEW WAS NOT AVAILABLE FOR THE REPORTED TIMEFRAME AS THE DEVICE HAD NOT BEEN SYNCED SINCE DECEMBER 2025. AVAILABLE INFORMATION FROM THE CLINICAL DIABETES SPECIALIST INDICATED THE USER HAD DISCONTINUED ILET THERAPY IN DECEMBER AND HAD NOT RESUMED USE PRIOR TO THE REPORTED DEATH. NO DEVICE MALFUNCTION WAS REPORTED OR IDENTIFIED. BASED ON AVAILABLE INFORMATION, THERE IS NO EVIDENCE SUGGESTING THE ILET CONTRIBUTED TO THE REPORTED DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 02-MAR-2026 IT WAS REPORTED THAT ON (B)(6) 2026, THE USER WAS FOUND DECEASED. NO ALLEGATION WAS MADE AGAINST THE DEVICE AND NO TREATMENT WAS REPORTED. THE OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811553 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death CGM: FREESTYLE LIBRE 3