BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19348745 · Received May 19, 2024

    Report

    Report Number
    3019004087-2024-00145
    Event Type
    Injury
    Date Received
    May 19, 2024
    Date of Event
    March 28, 2024
    Report Date
    May 19, 2024
    Manufacturer
    BETA BIONICS
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE ILET LOGS WERE REVIEWED BY BETA BIONICS FAILURE INVESTIGATION DEPARTMENT. DATA FOR THE DESCRIBED EVENT DATE OF 2024-03-28 WERE REVIEWED. NO INSTANCES OF MALFUNCTION ALERTS WERE FOUND IN THE DEVICE ENGINEERING LOGS. NO MOTOR ERRORS WERE SEEN TO INDICATE INACCURATE DOSING RELATIVE TO DELIVERY REQUESTS FOR INSULIN. THE ILET WAS FIRST INITIALIZED ON 2024-01-20. NO FACTORY RESETS WERE FOUND IN THE LOGS PRIOR TO THE EVENT DATE. HOWEVER, THE LOGS SHOW THE ILET WAS POWERED OFF 12 TIMES BETWEEN 2024-02-03 AND 2024-03-28, LEAVING THE ILET POWERED OFF FOR ANYWHERE FROM 20 SECONDS TO UP TO 6 CONSECUTIVE DAYS BEFORE POWERING IT BACK ON. ON 2024-03-14 ALONE, THE DEVICE WAS POWERED ON AND THEN OFF AGAIN FOUR TIMES BETWEEN 6:49 PM AND 9:23 PM. BODY WEIGHT WAS CHANGED 15 TIMES BETWEEN 2024-01-21 AND 2024-02-18. THE WEIGHT WAS ADJUSTED UP AND DOWN WITHIN A 10-POUND RANGE. BODY WEIGHT WAS CHANGED THREE TIMES ON 2024-02-14 AND FOUR TIMES ON 2024-02-16. THE LAST WEIGHT CHANGE PRIOR TO THE EVENT DATE ON 2024-02-18 AT 7:05 AM SET THE BODY WEIGHT BACK TO THE SAME THAT WAS USED TO INITIALIZE THE DEVICE. ON 2024-02-08, THE USER TURNED URGENT LOW SOON AND FALL RATE ALERTS OFF. ON 2024-03-10, THE ALERTS HAD REVERTED TO FACTORY SETTINGS, AND THE USER MANUALLY TURNED THE FALL RATE ALERT OFF AGAIN. AUDIO SETTING WAS SET TO LOW AT INITIALIZATION AND WAS NOT CHANGED. THE CGM TARGET, SLEEP CGM TARGET, AND SLEEP CGM TARGET START AND STOP TIMES WERE CHANGED EXCESSIVELY. THE CGM TARGET WAS CHANGED FROM "LOWER" TO "USUAL" ON 2024-03-26. THE LAST CARTRIDGE AND INFUSION SET (TEFLON CANNULA) CHANGE PRIOR TO THE EVENT DATE WAS LOGGED ON 2024-03-26 AT 10:54 AM. ON (B)(6) 2024, THE USER WENT TO THE INSERT CANNULA SCREEN TWICE BETWEEN 7:15 AM AND 7:30 AM BUT DID NOT COMPLETE THE PROCESS. REVIEW OF THE ILET REPORT SHOWS THE USER EXPERIENCED HYPERGLYCEMIA OVERNIGHT FROM (B)(6) 2024 INTO (B)(6) 2024, THE DAY OF THE EVENT. A "LESS THAN USUAL" DINNER MEAL WAS ANNOUNCED WHEN CGM GLUCOSE WAS 251 MG/DL AND STABLE. INSULIN WAS DOSED IN RESPONSE TO HYPERGLYCEMIA UNTIL IT WAS SUSPENDED AT 11:24 PM WHEN CGM GLUCOSE WAS 296 MG/DL AND BEGINNING TO TREND DOWN. SMALL DOSES OF INSULIN RESUMED WHEN CGM GLUCOSE STABILIZED IN RANGE BEFORE DOSING WAS SUSPENDED AGAIN AT 2:03 AM ON (B)(6) 2024, WHEN CGM GLUCOSE WAS 103 MG/DL. CGM GLUCOSE FIRST WENT BELOW RANGE AT 2:53 AM. IT ROSE ABOVE 70 MG/DL AND STAYED THERE FOR 25 MINUTES, WENT BELOW RANGE AGAIN FOR TWO HOURS UNTIL FINALLY RETURNING TO RANGE AT 6:38 AM. THE USER SPENT A TOTAL OF TWO HOURS LESS THAN 54 MG/DL ACROSS THE TWO PERIODS. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND IN THE ENGINEERING LOGS. THE ILET WAS BEHAVING AS INTENDED AND CAN BE SEEN REACTING APPROPRIATELY TO CGM GLUCOSE VALUES. THE ILET WAS APPROPRIATELY TRIGGERING DEVICE AND CGM GLUCOSE ALERTS. THESE ALERTS WERE NOT ACKNOWLEDGED UNTIL 6:19 AM BUT WERE CONSISTENTLY ACKNOWLEDGED AFTER THAT. 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 CASE NOTES, ILET REPORT, AND DEVICE LOGS, THE ILET OPERATED AS INTENDED BY DELIVERING OR SUSPENDING INSULIN IN RESPONSE TO RISING AND FALLING CGM GLUCOSE VALUES AND ALERTING THE USER APPROPRIATELY. IT IS EVIDENT THE USER WAS NOT USING THE DEVICE IN THE INTENDED WAY BY REPEATEDLY CHANGING BODY WEIGHT AND CGM TARGET SETTINGS AGAINST RECOMMENDATIONS AND NOT WEARING THE DEVICE FOR DAYS AT A TIME. HAVING THE DEVICE VOLUME SET TO LOW IMPACTED THE USER'S ABILITY TO RESPOND TO THE EVENT PROMPTLY, CONTRIBUTING TO THE SEVERITY OF THE EVENT. THE USER HAS DECIDED TO RETURN THE ILET.

    Description of Event or Problem · 0

    ON 4/23/24 AN ILET USER REPORTED THEY EXPERIENCED A LOW BLOOD GLUCOSE (BG) EVENT THAT REQUIRED ASSISTANCE IN TREATING. THE EVENT OCCURRED ON 3/28/24. THE USER REPORTED ON (B)(6) 2024 BETWEEN 2:42AM AND 6:27AM THEY HAD LOW BG (LEVEL NOT REPORTED) AND COULD NOT TREAT THEMSELVES. THE USER'S WIFE BROUGHT THE USER 100% JUICE (15 GRAMS OF CARBS) AND A GOGURT SQUEEZE (15 GRAMS OF CARBS). THE USER LAID BACK IN BED AND ABOUT 40 MINUTES LATER WAS ABLE TO EAT SOME SUGAR CEREAL ON THEIR OWN. THIS IS THE SECOND OF TWO LOW BG EVENTS REPORTED FOR THIS USER. THIS MEDWATCH REPORT DETAILS THE LOW BG EVENT ON 3/28/24. A MEDWATCH REPORT DETAILING THE SECOND LOW BG EVENT ON 4/16/24 IS SUBMITTED ON MFR REPORT #: 3019004087-2024-00144.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872540 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention