BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24153452 · Received January 22, 2026

    Report

    Report Number
    3019004087-2026-23762
    Event Type
    Death
    Date Received
    January 22, 2026
    Date of Event
    January 4, 2026
    Report Date
    January 22, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER BECAME AWARE ON 05-JAN-2026 THAT THE USER EXPERIENCED SEVERE HYPOGLYCEMIA ON 15-DEC-2025, FOLLOWED BY HOSPITALIZATION AND DEATH ON (B)(6) 2025. INFORMATION OBTAINED FROM THE HEALTHCARE PROVIDER AND THE USER¿S SPOUSE INDICATED THE PATIENT HAD ADVANCED METASTATIC PANCREATIC CANCER WITH ASSOCIATED RENAL AND HEPATIC FAILURE AND WAS RECEIVING HOSPICE-LEVEL CARE. THE USER WAS ADMITTED TO THE HOSPITAL FOR REFRACTORY HYPOGLYCEMIA, DURING WHICH INSULIN THERAPY WAS DISCONTINUED AND SUPPORTIVE CARE WAS PROVIDED. A REVIEW OF AVAILABLE DEVICE DATA SHOWED NO CONFIRMED DEVICE MALFUNCTION. INSULIN DELIVERY HAD BEEN PAUSED MORE THAN 30 HOURS PRIOR TO DEATH, AND THERE WAS NO INSULIN DELIVERY DURING DOCUMENTED HYPOGLYCEMIA. THE DEVICE CONTINUED TO RECEIVE CGM DATA UNTIL BATTERY DEPLETION OR SHUTDOWN NEAR THE END OF LIFE. THE DEVICE WAS NOT AVAILABLE FOR PHYSICAL EVALUATION, AS IT WAS REPORTEDLY DESTROYED AFTER THE USER¿S DEATH. BASED ON THE AVAILABLE CLINICAL INFORMATION, DEVICE DATA, AND REPORTED COMORBIDITIES, THE MANUFACTURER CONCLUDED THAT THE CAUSE OF DEATH WAS MOST CONSISTENT WITH COMPLICATIONS OF PROGRESSIVE HEPATIC AND RENAL FAILURE DUE TO METASTATIC PANCREATIC CANCER, WITH ASSOCIATED IMPAIRED INSULIN CLEARANCE LEADING TO REFRACTORY HYPOGLYCEMIA. THERE IS NO EVIDENCE TO INDICATE A DEVICE MALFUNCTION CONTRIBUTED TO THE OUTCOME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 05-JAN-2026, THE MANUFACTURER BECAME AWARE THAT ON 15-DEC-2025 THE USER EXPERIENCED HYPOGLYCEMIA WITH A REPORTED BLOOD GLUCOSE AS LOW AS 39 MG/DL, FOLLOWED BY SUBSEQUENT HYPERGLYCEMIA REACHING APPROXIMATELY 394 MG/DL. THE HYPOGLYCEMIA WAS TREATED WITH ORAL GLUCOSE AND EXOGENOUS INSULIN, WITH ASSISTANCE FROM CAREGIVERS. THE USER WAS HOSPITALIZED BEGINNING (B)(6) 2025, RECEIVED MEDICAL MANAGEMENT INCLUDING INSULIN AND INTRAVENOUS FLUIDS, AND DIED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213595 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| D DEXCOM G6 CGM