BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22733496 · Received August 6, 2025

    Report

    Report Number
    3019004087-2025-00770
    Event Type
    Death
    Date Received
    August 6, 2025
    Date of Event
    July 5, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BETA BIONICS, INC
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE ILET PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ENGINEERING ANALYSIS OF THE DEVICE LOG FILE COULD NOT BE COMPLETED AS THE DEVICE DATA LOGS HAVE NOT BEEN SYNCED AND HAS NOT YET BEEN RETURNED. A REQUEST FOR DEVICE RETURN HAS BEEN MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A FRIEND OF THE USER REPORTED THAT THE USER PASSED AWAY AT HOME ON (B)(6) 2025. THE FRIEND STATED THAT THE CAUSE OF DEATH WAS UNKNOWN AND THAT THE USER HAD REPORTEDLY NOT BEEN FEELING WELL PRIOR TO PASSING. THE USER WAS REPORTEDLY WEARING THE ILET AT THE TIME. NO ADDITIONAL DETAILS WERE PROVIDED, AND NO CONCERNS SPECIFIC TO THE DEVICE WERE RAISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365990 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death