BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19221827 · Received May 1, 2024

    Report

    Report Number
    3019004087-2024-00100
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    March 30, 2024
    Report Date
    May 1, 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 WERE FOUND IN THE DEVICE ENGINEERING LOGS. NO FACTORY RESET WAS FOUND IN THE LOGS. AUDIO SETTING WAS FOUND TO BE LOGGED AS "OFF" ON 2024-03-26 AT 6:43PM AND ALL CGM ALERTS WERE NOT CHANGED FROM FACTORY DEFAULTS (ALL ON). BODY WEIGHT WAS NOT CHANGED AFTER INITIAL ENTRY ON 2024-02-12. DATA FOR THE DESCRIBED EVENT DATE OF 2024-03-30 WAS REVIEWED. THE LAST CARTRIDGE CHANGE OPERATIONS PRIOR TO THE REVIEW DATE WAS ON 2024-03-26 AT 11:14PM WHILE THE LAST INFUSION SET CHANGE WAS ON 2024-03-15 AT 3:43AM. UNLESS OTHERWISE STATED, NO MOTOR ERRORS WERE SEEN TO INDICATE INACCURATE DOSING RELATIVE TO DELIVERY REQUESTS FOR INSULIN. ALL CGM GLUCOSE READINGS BELOW ARE MEASURED IN MG/DL. REVIEW OF THE ILET REPORT SHOWS A PERIOD OF BG-RUN MODE FOLLOWED BY A PROLONGED PERIOD OF HYPERGLYCEMIA RESULTING IN CORRECTION DOSING THEN FOLLOWED BY THE LOW GLUCOSE EVENT. CGM SIGNAL IS LOST DUE TO A FAILED SENSOR AT 5:21AM ON 2024-03-30. THE ILET CONTINUES TO DOSE BASAL INSULIN IN BG-RUN MODE UNTIL A CGM IS RECONNECTING AND PROVIDING GLUCOSE READINGS. WHEN THE CGM RECONNECTS AT 11:37AM, THE CGM GLUCOSE IS 284 MG/DL AND RISING. THE HYPERGLYCEMIA CONTINUES UNTIL 3:17PM WHEN IT BEGINS TO TREND DOWNWARD. INSULIN DOSING IS SUSPENDED WHEN THE GLUCOSE IS 267 MG/DL AND FALLING RAPIDLY. THE GLUCOSE REACHES 98 MG/DL AT 4:27PM AND REMAINS IN RANGE FOR APPROXIMATELY 2 HOURS BEFORE IT REACHES 62 MG/DL AT 6:27PM. THE TOTAL TIME LESS THAN 54 MG/DL WAS APPROXIMATELY 1 HOUR WITH A CGM GLUCOSE NADIR OF 39 MG/DL. THE GLUCOSE IS IN RANGE BY 7:37PM. THE ILET REPORT SHOWS MULTIPLE PERIODS HYPERGLYCEMIA WHERE THE ILET IS UNABLE TO DELIVER INSULIN DUE TO FAILURE TO MAINTAIN THE DEVICE PROPERLY. THE REPORT ALSO SHOWS THAT THE USER IS NOT ANNOUNCING MEALS WHICH ALSO CONTRIBUTE TO HYPERGLYCEMIA AND THE NEED FOR THE ILET TO INCREASE INSULIN DOSING. NO EVIDENCE OF DEVICE MALFUNCTION WERE FOUND IN THE ENGINEERING LOGS. THE ILET DEVICE WAS FOND TO BE TRIGGERING ALL CGM GLUCOSE RELATED ALERTS APPROPRIATELY AND WERE NOT ACKNOWLEDGED. THE ILET WAS FOUND TO BE MAKING BASAL REQUESTS CONTINUOUSLY IN 5-10 MINUTE INTERVALS THROUGHOUT THE HIGH EVENT, BUT NOT MAKING BASAL REQUESTS THROUGHOUT THE LOW EVENT. FOLLOWING THE LOW EVENT, THE ILET DID NOT RESUME BASAL 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, ILET REPORT AND DEVICE LOGS, IT WAS DETERMINED THAT THE ILET OPERATED AS INTENDED. THE ASSIGNABLE CAUSE TO THIS LOW GLUCOSE EVENT INCLUDES A PERIOD OF PROLONGED HYPERGLYCEMIA WHICH REQUIRED CORRECTION INSULIN. THE USER'S DEVICE VOLUME WAS TURNED OFF AND ALERTS WERE NOT ACKNOWLEDGED WHICH MAY HAVE LIMITED THE USER'S ABILITY TO BE NOTIFIED AND RESPOND TO THE LOW GLUCOSE AND POTENTIALLY INCREASED THE SEVERITY OF THE EVENT.

    Description of Event or Problem · 0

    ON 4/1/24 A BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) WAS NOTIFIED BY AN ILET USER THAT THEY EXPERIENCED A LOW BLOOD GLUCOSE (BG) EVENT REQUIRING EMS. THE EVENT OCCURRED ON 3/30/24. UPON FURTHER FOLLOW-UP WITH THE USER, THEY REPORTED NOT ANNOUNCING MEALS AND, FELT THE ILET WAS TOO AGGRESSIVE WITH A CORRECTION WHICH CAUSED THE LOW BG EVENT. THE USER REPORTED THEY EXPERIENCED LOSS OF CONSCIOUSNESS, DIZZINESS, AND A SEIZURE. THEIR WIFE GAVE THEM 4 GLUCOSE GEL PACKETS ALONG WITH ORANGE JUICE. THE WIFE CALLED EMS AND THEY ADMINISTERED A GLUCOSE IV. THE USER REPORTED THEIR BG LEVEL WAS 16 MG/DL. THE USER WAS NOT TAKEN TO THE HOSPITAL. PRIOR TO THIS LOW BG EVENT, THE CDS HAD SPOKEN WITH THE USER AND PROVIDED RE-EDUCATION THE USER EXPRESSED CONCERN THAT THE ILET HAS BEEN GIVING TOO MUCH INSULIN AND CAUSING HYPOGLYCEMIA. THE CDS REVIEWED THE ILET REPORT WITH THEM ON THE PHONE. THEY HAD NOT BEEN ANNOUNCING MEALS AND STATED THAT THEY HAD BEEN DISCONNECTING FROM THE ILET FOR SEVERAL HOURS AT A TIME. THE CDS REINFORCED THAT THE ILET STOPS INSULIN DELIVERY WHEN GLUCOSE LEVELS ARE LOW. THE CDS ADVISED THE USER TO NOT TAKE THE ILET OFF FOR EXTENDED PERIODS OF TIME AS THAT WILL CAUSE BG LEVELS TO RISE, THE ILET WILL INCREASE INSULIN DOSING AND COULD RESULT IN HYPOGLYCEMIA. AT THE TIME OF THIS CALL THE USER WAS DISCONNECTED FROM THE ILET AND THEIR BG WAS IN THE 300-400 MG/DL RANGE. THE CDS ADVISED THE USER THAT THEY NEED INSULIN - EITHER BY INJECTION OR BY RESUMING THE ILET. THE USER SAID THEY WOULD RECONNECT TO THE ILET LATER. THE CDS ALSO CAUTIONED THE USER THAT THEY MAY EXPERIENCE HYPOGLYCEMIA AND EMPHASIZED TREATMENT OF HYPOGLYCEMIA WHEN APPROPRIATE. THE USER VERBALIZED UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147115 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