BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24464434 · Received February 26, 2026

    Report

    Report Number
    3019004087-2026-33618
    Event Type
    Death
    Date Received
    February 26, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 26, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER EXPERIENCED CARDIAC ARREST RESULTING IN DEATH, AND THE ILET WAS REPORTEDLY TURNED ON WITHIN 24 HOURS PRIOR TO THE EVENT. ENGINEERING LOG REVIEW DID NOT IDENTIFY MALFUNCTION ALERTS OR A FACTORY RESET. AVAILABLE DEVICE DATA IN THE DAYS PRIOR TO DEATH SHOWED PROLONGED HYPERGLYCEMIA, REPEATED OCCLUSION ALERTS, PERIODS WITHOUT INSULIN (CARTRIDGE OUT OF INSULIN AND NOT REPLACED), AND LOSS OF CGM DATA DUE TO SENSOR FAILURE WITH SUBSEQUENT DOSING CESSATION; ENGINEERING LOGS WERE NOT AVAILABLE AFTER (B)(6) 2026 AND NO CGM DATA WAS AVAILABLE ON THE DATE OF DEATH. BECAUSE CLINICAL DETAILS SURROUNDING THE CARDIAC ARREST ARE LIMITED AND DEVICE DATA IS INCOMPLETE AT THE TIME OF DEATH, A CAUSAL RELATIONSHIP BETWEEN ILET USE AND THE REPORTED DEATH CANNOT BE CONFIRMED; THE HEALTHCARE PROVIDER ALSO REPORTED THE USER HAD SIGNIFICANT UNDERLYING ILLNESS. BASED ON AVAILABLE INFORMATION, THE EVENT REMAINS CAUSE NOT ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE (INCLUDING DEVICE RETURN/LOG RETRIEVAL), A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 09-FEB-2026 A DIABETES EDUCATOR REPORTED THAT ON (B)(6) 2026 THE USER EXPERIENCED CARDIAC ARREST AND DIED, AND THE ILET HAD BEEN TURNED ON WITHIN 24 HOURS PRIOR TO DEATH. EMERGENCY MEDICAL SERVICES RESPONDED, ADDITIONAL TREATMENT DETAILS ARE UNKNOWN. THE OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526520 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death DEXCOM G7 CGM