BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22538616 · Received July 17, 2025

    Report

    Report Number
    3019004087-2025-00656
    Event Type
    Death
    Date Received
    July 17, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BETA BIONICS, INC
    Product Code
    QFG
    UDI-DI
    850050080015
    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

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE ILET PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. DEVICE LOGS WERE NOT AVAILABLE FOR THE DATE OF THE REPORTED DEATH, BUT AVAILABLE DATA SHOWED NO MALFUNCTION ALERTS OR DOSING ANOMALIES. THE ILET RESPONDED TO CGM GLUCOSE VALUES AS INTENDED, AND INSULIN DELIVERY REQUESTS WERE OBSERVED AT REGULAR INTERVALS. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED. BASED ON INFORMATION PROVIDED BY THE HCP AND ENGINEERING LOG REVIEW, THE CAUSE OF DEATH COULD NOT BE LINKED TO A DEVICE-RELATED FAILURE. DEVICE DATA INDICATE THAT ON (B)(6) 2025, THE USER EXPERIENCED HYPOGLYCEMIA BEGINNING AT 6:41 PM, LASTING APPROXIMATELY 40 MINUTES, FOLLOWED BY A SUSTAINED PERIOD OF HYPERGLYCEMIA. THIS MAY HAVE BEEN DRIVEN BY BOTH OVERTREATMENT OF THE LOW- EVIDENCED BY A CGM RISE FROM 69 MG/DL AT 7:16 PM TO 126 MG/DL FIVE MINUTES LATER, WITH CONTINUED ELEVATION THEREAFTER REACHING >400 MG/DL BY 10:40 PM - AND INADEQUATE INSULIN DELIVERY FOLLOWING A 5:54 PM OCCLUSION ALARM. NO CARTRIDGE OR INFUSION SET CHANGE WAS PERFORMED DURING THIS PERIOD, AND MULTIPLE ALARMS WERE TRIGGERED, INCLUDING HIGH GLUCOSE, CGM SIGNAL LOSS, AND LOW BATTERY. THE DEVICE POWERED DOWN DUE TO BATTERY DEPLETION ON (B)(6) 2025 AT 10:47[?]AM, WITH CGM GLUCOSE REMAINING SUSTAINED AT >400MG/DL IN THE HOURS PRECEDING SHUTDOWN. IT REMAINS UNCLEAR WHETHER THE USER RESUMED THERAPY WITH THE ILET THEREAFTER DUE TO LACK OF DEVICE LOG DATA. WHILE THIS SEQUENCE OF EVENTS MAY HAVE CONTRIBUTED TO THE RISK FOR DKA, THE EVENTS THAT OCCURRED BETWEEN DEVICE SHUTDOWN AND THE USER'S DEATH ON (B)(6) 2025 ARE UNKNOWN. OTHER CONTRIBUTING FACTORS ARE LIKELY, INCLUDING A HISTORY OF RECURRENT DKA AND DOCUMENTED SOCIAL CONCERNS FROM THE HEALTHCARE PROVIDER. BASED ON AVAILABLE DEVICE LOG DATA, NO DEVICE MALFUNCTION WAS IDENTIFIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 15-APR-2025, BETA BIONICS WAS NOTIFIED BY A HEALTHCARE PROVIDER (HCP) THAT THE USER HAD PASSED AWAY. ACCORDING TO THE HCP, THE ILET WAS NOT CONSIDERED A CONTRIBUTING FACTOR. THE USER HAD REPORTEDLY BEEN HOSPITALIZED DAYS PRIOR FOR DIABETIC KETOACIDOSIS (DKA) AND HAD A DOCUMENTED HISTORY OF MULTIPLE DKA HOSPITALIZATIONS. THE HCP NOTED ONGOING CONCERNS REGARDING INADEQUATE DIABETES MANAGEMENT BY THE USER'S CAREGIVER AND INDICATED THAT THESE CONCERNS HAD BEEN REPORTED TO CHILD PROTECTIVE SERVICES IN THE PAST. THE ILET WAS NOT RETURNED, AND DEVICE LOGS WERE LAST SYNCED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565779 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Death| H DEXCOM G7 CONTINUOUS GLUCOSE MONITOR