BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 21482585 · Received February 27, 2025

    Report

    Report Number
    3019004087-2025-00133
    Event Type
    Death
    Date Received
    February 27, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BETA BIONIC, INC.
    Product Code
    QFG
    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

    BASED UPON THE EVENT INFORMATION AND INVESTIGATION THE USER WAS NOT WEARING THE ILET AT THEIR TIME OF DEATH, A SPECIFIC CAUSE OF DEATH COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. AVAILABLE ILET LOGS WERE REVIEWED. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND IN THE ENGINEERING LOGS. THE ILET WAS PERFORMING AS INTENDED AND REACTED APPROPRIATELY TO AVAILABLE CGM GLUCOSE VALUES AND TRIGGERING CGM GLUCOSE ALERTS UNTIL SENSOR READINGS STOPPED AT 1:56AM ON (B)(6) 2025. SENSOR UNAVAILABLE AND REPLACE SENSOR ALERTS WERE TRIGGERED BUT NOT ACKNOWLEDGED. ALERTS WARNING OF IMPENDING SUSPENSION OF INSULIN DELIVERY WERE TRIGGERED BUT NOT ACKNOWLEDGED. INSULIN DELIVERY STOPPED AT 10:06AM ON (B)(6) 2025. ALERTS WARNING OF IMPENDING LOSS OF POWER WERE TRIGGERED BUT WERE NOT ACKNOWLEDGED. THE ILET RAN OUT OF POWER AT 3:30PM (B)(6) 2025. THE USER WAS REPORTEDLY FOUND UNCONSCIOUS IN THEIR YARD SOMETIME IN THE AFTERNOON, EXACT TIME UNKNOWN. AVAILABLE INFORMATION INDICATES THE USER WAS NOT USING THE ILET AT THE TIME OF DEATH ON (B)(6) 2025. THE REPORTED CAUSE OF DEATH APPEARS RELATED TO UNDERLYING DIABETES. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6)2025, THE MANUFACTURER WAS NOTIFIED BY A CLINICAL DIABETES SPECIALIST (CDS) THAT THE USER WAS ADMITTED TO THE HOSPITAL WITH SUSPECTED DIABETIC KETOACIDOSIS (DKA). THE USER'S DAUGHTER REPORTED THAT A NEIGHBOR FOUND THE USER UNCONSCIOUS IN THEIR YARD BEFORE BEING TRANSPORTED TO THE HOSPITAL. THE USER TESTED POSITIVE FOR KETONES AND WAS DIAGNOSED WITH DKA. THE USER WAS INTUBATED AND TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. ON (B)(6) 2025 THE DAUGHTER CONFIRMED THE USER REMAINED IN THE HOSPITAL UNTIL PASSING AWAY ON (B)(6) 2025.

    Description of Event or Problem · 0

    ON 30-JAN-2025, IT WAS REPORTED THAT THE USER WAS FOUND UNCONSCIOUS IN THEIR YARD ON (B)(6) 2025. THEY WERE TRANSPORTED TO THE HOSPITAL AND TREATED FOR DKA. THE USER REMAINED IN THE HOSPITAL UNTIL PASSING AWAY 15 DAYS LATER ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596243 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONIC, INC. BB1001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Hospitalization| D FREESTYLE LIBRE 3 PLUS CGM