BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19288249 · Received May 10, 2024

    Report

    Report Number
    3019004087-2024-00121
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    March 30, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BETA BIONICS
    Product Code
    QFG
    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

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE ILET LOGS WERE REVIEWED BY BETA BIONICS FAILURE INVESTIGATION DEPARTMENT. NO INSTANCES OF MALFUNCTION ALERTS WERE FOUND IN THE DEVICE ENGINEERING LOGS. A FACTORY RESET WAS FOUND IN THE LOGS ON 2024-03-02. AUDIO SETTING WAS FOUND TO BE LOGGED AS "OFF" ON 2024-03-08 AND ALL CGM ALERTS WERE NOT CHANGED FROM FACTORY DEFAULTS (ALL ON). BODY WEIGHT WAS REENTERED FOLLOWING THE FACTORY RESET. LOGS INDICATE THAT THE ILET WAS POWERED OFF ON 2024-03-26 AND WAS NOT POWERED BACK ON UNTIL 2024-03-28. DATA ON THE REPORTED EVENT DATE OF 2024-03-30 WAS REVIEWED. THE LAST INFUSION SET CHANGE LOGGED IN THE ILET PRIOR TO THE REVIEW DATE WAS ON 2024-03-02 WHILE THE LAST CARTRIDGE CHANGE WAS ON 2024-03-23. UNLESS OTHERWISE STATED, NO MOTOR ERRORS WERE SEEN TO INDICATE INACCURATE DOSING RELATIVE TO DELIVERY REQUESTS FOR INSULIN. REVIEW OF THE ILET REPORT SHOWS THE LAST CGM GLUCOSE AVAILABLE IN THE ILET PRIOR TO THE EVENT WAS ON 2024-03-21. THE ILET ENTERS BG-RUN MODE AT THIS TIME AND DELIVERS BASAL INSULIN APPROPRIATELY. THERE ARE SEVERAL INSTANCES WHERE THE REQUIRED BG ENTRIES WERE NOT COMPLETED, AND INSULIN IS SUSPENDED UNTIL A BG VALUE IS ENTERED. ALL INSULIN DOSING IS STOPPED ON 2024-03-24, 72 HOURS AFTER ENTERING BG-RUN MODE. THERE ARE SEVERAL ADDITIONAL BG VALUES ENTERED INTO THE ILET, BUT THE ILET IS UNABLE TO RESPOND DUE TO BG-RUN MODE EXPIRATION. CGM GLUCOSE VALUES ARE NOT AVAILABLE AGAIN UNTIL 2024-04-01. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND IN THE ENGINEERING LOGS. THE ILET BEHAVED AS INTENDED BY ENTERING BG-RUN MODE WHEN NO CGM SENSOR WAS CONNECTED. WITH MANUAL BG VALUES BEING ENTERED, THE ILET CONTINUED TO MAKE BASAL REQUESTS FOR INSULIN DELIVERY IN BG-RUN MODE. AFTER 72 HOURS WITHOUT A CGM SENSOR CONNECTED, THE ILET TRIGGERED ALERT 92, "DOSING STOPPED", AND BG-RUN WAS DISABLED. NO PRODUCT PERFORMANCE ISSUES WERE IDENTIFIED. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED AND INVESTIGATED ACCORDINGLY. NO ANOMALIES WERE OBSERVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING RELEASE CRITERIA FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE REVIEW OF THE CASE NOTES, ILET REPORT AND DEVICE LOGS, THE ILET OPERATED AS INTENDED WITHIN THE LIMITS OF BG-RUN MODE. THE ASSIGNABLE CAUSE FOR THIS HYPERGLYCEMIC EVENT IS A FAILURE TO PROMPTLY REPLACE THE CGM SENSOR, LEADING TO INSULIN SUSPENSION DUE TO BG-RUN MODE EXPIRATION, AS WELL AS A FAILURE TO APPROPRIATELY RESORT TO A BACKUP THERAPY PLAN.

    Description of Event or Problem · 0

    ON (B)(6) 24 A BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) REPORTED AN ILET USER EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT LEADING TO DIABETIC KETOACIDOSIS (DKA) AND HOSPITALIZATION. THE EVENT OCCURRED ON (B)(6) 24. THE CDS COLLECTED EVENT DETAILS FROM THE USER'S MOTHER AND HEALTHCARE PROVIDER (HCP). THE USER'S DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM) HAD FALLEN OFF AND THE USER DID NOT INFORM THEIR MOTHER THAT IT WAS THEIR LAST SENSOR. THE ILET THEN ENTERED BG RUN MODE AND FOR A FEW DAYS THE USER WAS MANUALLY ENTERING THEIR BG UNTIL WEDNESDAY (B)(6) 24 WHEN THE ILET WOULD NO LONGER ACCEPT BG VALUES. THE ILET THEN STOPPED DELIVERING INSULIN. THE MOTHER REPORTED THE FAILED CGM TO DEXCOM, BUT THE REPLACEMENT HAD NOT ARRIVED. THE MOTHER TOLD THE USER TO REVERT BACK TO THEIR PREVIOUS THERAPY BUT IS UNSURE IF THE USER EVER DID. ON FRIDAY (B)(6) 24 THE USER CAME HOME FROM THEIR SOCCER GAME WITH HIGH BG. THE MOTHER REQUESTED THE USER DRINK WATER, TAKE LANTUS, AND FAST ACTING INSULIN. THE MOTHER THEN WENT TO BED. THE NEXT MORNING, (B)(6) 24, THE MOTHER WOKE UP AND THE USER'S BG WAS IN THE 450 MG/DL RANGE. THE MOTHER WOKE THE USER UP AND THE USER WAS LETHARGIC, HAD ALTERED MENTAL STATUS, AND HAD URINATED THE BED. THE MOTHER THEN CALLED 911. THE USER WAS TRANSPORTED TO THE HOSPITAL AND WAS ADMITTED SATURDAY (B)(6) 24. THE USER WAS TREATED WITH FLUIDS AND INSULIN THROUGH AN IV. THE USER REMAINED IN THE HOSPITAL THROUGH MONDAY (B)(6) 24 SO THE USER COULD RECEIVE DIABETES EDUCATION BEFORE DISCHARGE. PRIOR TO LEAVING HOSPITAL THE USER RECEIVED DIABETES EDUCATION AND WAS PUT BACK ON A CGM AND ILET. THE MOTHER REPORTED THE USER HAS BEEN DOING REALLY WELL SINCE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498676 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.