BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19177011 · Received April 24, 2024

    Report

    Report Number
    3019004087-2024-00092
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 24, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BETA BIONICS
    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

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE ILET LOGS WERE REVIEWED BY BETA BIONICS FAILURE INVESTIGATION DEPARTMENT. NO INSTANCES OF MALFUNCTION ALERTS ASSOCIATED WITH DRUG DELIVERY WERE FOUND IN THE DEVICE ENGINEERING LOGS. AUDIO SETTING WAS FOUND TO BE LOGGED AS "LOW" ON (B)(6) 2024 AND ALL CGM ALERTS WERE NOT CHANGED FROM FACTORY DEFAULTS (ALL ON). BODY WEIGHT WAS SET ON (B)(6) 2024 AFTER THE FACTORY RESET. DATA FOR THE DESCRIBED EVENT DATE OF 2024-03-24 WAS REVIEWED. NO INSTANCES OF BG-RUN MODE WERE LOGGED ON THE REVIEW DATE. UNLESS OTHERWISE STATED, NO MOTOR ERRORS WERE SEEN TO INDICATE INACCURATE DOSING RELATIVE TO DELIVERY REQUESTS FOR INSULIN. REVIEW OF THE ILET REPORT AND DEVICE LOGS SHOW A PERIOD OF HYPERGLYCEMIA FROM 11:18AM THROUGH 1:17PM. THE HIGHEST CGM GLUCOSE IS 208 MG/DL. A "USUAL" SIZED LUNCH WAS DELIVERED APPROXIMATELY 3 HOURS PRIOR TO THE EVENT. THE CGM GLUCOSE BEGINS TO TREND DOWNWARD AND REACHES 66 MG/DL 2:57PM AND REMAINS LOW FOR A TOTAL OF 60 MINUTES (TOTAL TIME BELOW 54 MG/DL WAS 45 MINUTES). THE CGM GLUCOSE REACHED A NADIR OF 39 MG/DL. THE ILET REPORT SHOWS APPROPRIATE DOSING AND SUSPENSION OF INSULIN IN RESPONSE TO THE CGM GLUCOSE. ALL THE LOW ALERTS WERE TRIGGERED APPROPRIATELY PRIOR TO AND THROUGHOUT THE EVENT BUT WERE NEVER ACKNOWLEDGED. DURING THE SEVERAL DAYS PRIOR TO THE EVENT, THE REPORT SHOWS PERIODS OF SIMILAR INSULIN DOSING WHICH DO NOT RESULT IN HYPOGLYCEMIA. NO EVIDENCE OF MALFUNCTION WERE FOUND IN THE DEVICE ENGINEERING LOGS. THE ILET WAS FOUND TO BE TRIGGERING THE LOW GLUCOSE ALERTS APPROPRIATELY AND WAS NOT SEEN MAKING BASAL DELIVERY REQUESTS FOR INSULIN THROUGHOUT THE LOW EVENT AND DID NOT RESUME REQUESTS UNTIL AFTER CGM GLUCOSE READINGS WERE AT LEAST 100MG/DL AND NOT DECREASING. 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, DEVICE LOGS AND ILET REPORT IT WAS DETERMINED THAT THE ILET OPERATED AS INTENDED. THE LIKELY ASSIGNABLE CAUSES TO THIS EVENT INCLUDE FAILURE TO TREAT HYPOGLYCEMIA PROMPTLY RESULTING IN A PROLONGED HYPOGLYCEMIC EVENT. THE DEVICE VOLUME BEING SET TO "LOW" LIKELY LIMITED THE USER'S ABILITY TO HEAR THE ALERTS WHILE DRIVING AND APPROPRIATELY RESPOND TO LOW GLUCOSE ALERTS. THE MEAL ANNOUNCEMENT WAS ALSO DELIVERED LATER IN THE HYPERGLYCEMIC EXCURSION SUGGESTING THAT THE USER ANNOUNCED LATE RELATIVE TO WHEN THEY STARTED EATING, WHICH MAY HAVE ALSO CONTRIBUTED TO HYPOGLYCEMIA. IT IS ALSO POSSIBLE THAT THE CARBOHYDRATE CONTENT THAT THE USER CONSUMED DID NOT ALIGN WITH THE CHOSEN MEAL ANNOUNCEMENT RESULTING IN A LONGER POST-PRANDIAL GLUCOSE EXCURSION AND EXCESS INSULIN DELIVERY RELATIVE TO THEIR INSULIN NEED. THE USER HAS DECIDED TO DISCONTINUE ILET USE AND RETURN THE DEVICE.

    Description of Event or Problem · 0

    ON 3/25/2024 A BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) REPORTED AN ILET USER EXPERIENCED A LOW BLOOD GLUCOSE (BG) EVENT AND WAS IN A CAR ACCIDENT. THE EVENT OCCURRED ON 3/24/2024. THE USER STATED THEY WERE DRIVING DOWN THE FREEWAY, TRYING TO EXIT AND CRASHED INTO ANOTHER VEHICLE. THE USER STATED THEY PASSED OUT WHEN THEY STOOD UP TO GET OUT OF THE CAR AND THEN PASSED OUT AGAIN AFTER THE INITIAL EVENT. EMS ARRIVED AND THE USER'S BG WAS 39 MG/DL. IV GLUCOSE WAS ADMINISTERED, AND THE USER WAS TRANSPORTED TO THE HOSPITAL. THE USER WAS ADMITTED TO THE HOSPITAL, DISCONNECTED FROM THE ILET AND REPORTED HAVING A BROKEN LEFT KNEE AND POSSIBLY A BROKEN ANKLE. THE USER NOTED THEY ARE "ALWAYS SNACKING" AND EATING "MORE THAN USUAL". THE USER WOULD ANNOUNCE A "USUAL" MEAL BUT FELT DOSES WERE TOO HIGH SO THEY WOULD THEN EAT EXTRA IN AN EFFORT TO PREVENT HYPOGLYCEMIA. THE USER INQUIRED ABOUT GETTING RESTARTED ON THE ILET. THE CDS ADVISED DOING A FACTORY RESET AND RE-EDUCATION PRIOR TO RESTARTING ONCE THEY WERE DISCHARGED. THE CDS FOLLOWED UP WITH THE USER ON (B)(6) 2024 AND THEY WERE STILL IN THE HOSPITAL BUT WAS GOING TO BE TRANSFERRED TO A SKILLED NURSING FACILITY. THE CDS CONTACTED THE USER'S HCP OFFICE AND UPDATED THE EDUCATOR WHO WAS ALSO FOLLOWING THE USER. THEY WILL UPDATE BETA BIONICS AS NEEDED IF ANY ADDITIONAL INFORMATION IS RECEIVED ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604502 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization