BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22499519 · Received July 14, 2025

    Report

    Report Number
    3019004087-2025-00397
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    February 23, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BETA BIONICS, INC
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS WERE IDENTIFIED; THE ILET FUNCTIONED WITHIN SPECIFICATION. INSULIN DELIVERY AND SUSPENSION OCCURRED AS EXPECTED IN RESPONSE TO CGM VALUES AND MEAL ANNOUNCEMENTS. PREDICTIVE AND THRESHOLD-BASED HYPOGLYCEMIA ALARMS WERE APPROPRIATELY TRIGGERED BUT NOT ACKNOWLEDGED. DESPITE AUTOMATIC SUSPENSION OF INSULIN DELIVERY IN RESPONSE TO FALLING GLUCOSE LEVELS, SUSTAINED HYPOGLYCEMIA (CGM <54MG/DL) WAS OBSERVED BEGINNING AT APPROXIMATELY 00:19 ON (B)(6) 2025. A CGM SENSOR ISSUE WAS SUBSEQUENTLY REPORTED, FOLLOWED BY SENSOR FAILURE AND LOSS OF GLUCOSE DATA. BASED ON ALL AVAILABLE INFORMATION, THE ILET SYSTEM OPERATED AS INTENDED. THERE IS NO EVIDENCE TO SUGGEST THAT THE ILET CAUSED OR CONTRIBUTED TO THE USER'S DEATH. THE DOCUMENTED CAUSE OF DEATH WAS HYPERTENSIVE AND ATHEROSCLEROTIC CORONARY HEART DISEASE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO DOCUMENT THE USER'S VOLUNTARY MEDWATCH SUBMISSION RELATED TO THE PREVIOUSLY REPORTED EVENT. THE INFORMATION CONTAINED IN THE VOLUNTARY SUBMISSION IS CONSISTENT WITH THE ORIGINALLY SUBMITTED MDR.

    Description of Event or Problem · 0

    ON 14-APR-2025, BETA BIONICS WAS CONTACTED BY (B)(6) REGARDING THE DEATH OF A 56-YEAR-OLD MALE WHO HAD BEEN USING THE ILET. THE MEDICAL EXAMINER REQUESTED DEVICE EVALUATION, AS THE USER WAS WEARING THE DEVICE AT THE TIME OF PASSING. THE ILET WAS SUBSEQUENTLY RETURNED TO BETA BIONICS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273193 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1