BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24173031 · Received January 23, 2026

    Report

    Report Number
    3019004087-2026-24090
    Event Type
    Death
    Date Received
    January 23, 2026
    Date of Event
    December 14, 2025
    Report Date
    January 23, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER BECAME AWARE ON 26-DEC-2025 THAT THE USER EXPERIENCED A FATAL EVENT ON (B)(6) 2025 FOLLOWING A PERIOD OF SIGNIFICANT BLOOD GLUCOSE INSTABILITY. INFORMATION WAS OBTAINED FROM A HEALTHCARE PROFESSIONAL AND A FAMILY MEMBER INDICATING THE USER HAD ADVANCED PANCREATIC CANCER WITH ASSOCIATED LIVER AND KIDNEY FAILURE AND WAS RECEIVING HOSPICE-LEVEL CARE. THE USER WAS REPORTED TO HAVE EXPERIENCED REFRACTORY HYPOGLYCEMIA EARLIER DURING HOSPITALIZATION AND SUBSEQUENT HYPERGLYCEMIA PRIOR TO DEATH. AVAILABLE DEVICE DATA SHOW INSULIN DELIVERY HAD BEEN PAUSED FOR MORE THAN 24 HOURS PRIOR TO THE REPORTED DEATH, WITH NO INSULIN DELIVERY RECORDED DURING THAT PERIOD, WHILE CONTINUOUS GLUCOSE MONITORING DATA CONTINUED TO BE RECEIVED. NO INSULIN DELIVERY WAS RECORDED DURING HYPOGLYCEMIA EVENTS, AND NO EXCESSIVE OR UNINTENDED INSULIN DELIVERY WAS IDENTIFIED IN THE AVAILABLE DATA. ENGINEERING LOGS DID NOT IDENTIFY ANY CONFIRMED DEVICE MALFUNCTION, AND THE DEVICE WAS NOT AVAILABLE FOR PHYSICAL EVALUATION AS IT WAS DISCARDED AFTER THE EVENT. BASED ON THE INFORMATION AVAILABLE, THE EVENT APPEARS MOST CONSISTENT WITH THE USER¿S RAPIDLY DETERIORATING CLINICAL CONDITION, INCLUDING ADVANCED METASTATIC DISEASE WITH RENAL AND HEPATIC FAILURE, RESULTING IN IMPAIRED INSULIN CLEARANCE AND SEVERE GLYCEMIC INSTABILITY. THERE IS NO EVIDENCE TO CONFIRM THAT DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE DEATH. IF ADDITIONAL INFORMATION OR DEVICE DATA BECOME AVAILABLE, THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ON 26-DEC-2025, THE MANUFACTURER BECAME AWARE THAT THE USER EXPERIENCED HYPERGLYCEMIA WITH REPORTED BLOOD GLUCOSE VALUES GREATER THAN 400 MG/DL ON (B)(6) 2025. THE USER WAS NOT REPORTED TO HAVE RECEIVED SUCCESSFUL TREATMENT FOR THE ELEVATED BLOOD GLUCOSE PRIOR TO THE EVENT. EMERGENCY MEDICAL SERVICES WERE CALLED, RESUSCITATION WAS ATTEMPTED, AND THE USER WAS PRONOUNCED DECEASED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233920 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death DEXCOM G7 CGM