BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19053948 · Received April 5, 2024

    Report

    Report Number
    3019004087-2024-00071
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 5, 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 2024-02-12 AND ALL CGM ALERTS WERE NOT CHANGED FROM FACTORY DEFAULTS (ALL ON). BODY WEIGHT WAS NOT CHANGED AFTER 2024-02-06. DATA FOR THE DESCRIBED EVENT DATE OF 2024-03-04 WAS REVIEWED. THE LAST CARTRIDGE CHANGE OPERATION PRIOR TO THE REVIEW DATE WAS ON 2024-03-03 AT 7:30PM WHILE THE LAST INFUSION SET CHANGE WAS ON THE SAME DATE AT 9:37PM. 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 PERIOD OF PROLONGED HYPERGLYCEMIA STARTING ON 2024-03-03 AT 8:09PM AND INTO 2024-03-04. THE CGM GLUCOSE IS ABOVE 400 MG/DL BY 9:44PM AND REMAINS THERE FOR THE DURATION OF THE EVENT. PRIOR TO THE START OF THE HYPERGLYCEMIA, INSULIN DOSING WAS STOPPED FOR 1 HOUR AND 50 MINUTES DUE TO AN INCOMPLETE CARTRIDGE LOAD AND INFUSION SET CHANGE. AFTER THE INSULIN DOSING RESUMES AND THE BG IS 300 MG/DL. THE USER ANNOUNCES A "MORE" SIZED DINNER ANNOUNCEMENT AT 11:54PM ON 2024-03-03. THERE ARE TWO PERIODS OF BG-RUN MODE RELATED TO CGM SENSOR ERRORS DURING THE HYPERGLYCEMIC EVENT, ONE LASTING 60 MINUTES AND THE SECOND PERIOD 4 HOURS. THE USER'S INSULIN CARTRIDGE RUNS LOW AT 7:26AM ON 2024-03-04 AND IS NOT REPLACED UNTIL 2 HOURS LATER. THE ILET APPEARS TO BE DOSING INSULIN APPROPRIATELY IN RESPONSE TO THE CGM GLUCOSE. BASED ON THE DEVICE ENGINEERING LOGS, NO EVIDENCE OF MALFUNCTION WERE FOUND. THE ILET APPROPRIATELY TRIGGERED THE HIGH GLUCOSE ALERT AS WELL AS SUPPLY ALERTS. NONE OF THE ALERTS WERE FOUND TO HAVE BEEN MARKED AS "ACKNOWLEDGED." THE ILET WAS ALSO FOUND TO BE CONSISTENTLY MAKING BASAL DELIVERY REQUESTS FOR INSULIN THROUGHOUT THE HIGH EVENT, ONLY STOPPING WHEN A CARTRIDGE CHANGE WAS IN PROGRESS OR WHEN THE CARTRIDGE WAS EMPTY. THE ILET ALSO WAS FOUND TO HAVE APPROPRIATELY ENTERED BG-RUN MODE WHEN THE CGM TRANSMITTER EXPERIENCED AN ERROR. 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 EVENT IS THE INCOMPLETE CARTRIDGE CHANGE WHICH LEAD TO A PROLONGED PERIOD WITHOUT INSULIN, THE INFUSION SITE FAILURE AS EVIDENCED BY THE REPORT OF A BENT CANNULA AND THE BG REMAINING UNAFFECTED BY INSULIN DOSING. ADDITIONALLY, THE DEVICE VOLUME BEING SET TO "OFF" MAY HAVE LIMITED THE USER'S ABILITY TO PROMPTLY RESPOND TO ALARMS AND FAILURE TO FOLLOW THE RECOMMENDATIONS FOR MANAGEMENT OF HYPERGLYCEMIA AND SWITCH OUT THE INFUSION SITE ALSO CONTRIBUTED TO THIS EVENT. THE HCP FELT THE USER WOULD BENEFIT FROM USING CONTACT DETACH INFUSION SETS INSTEAD. THE HCP REQUESTED THAT THE CDS PROVIDE FOLLOW UP EDUCATION ON INFUSION SITE, TUBING, AND CARTRIDGE CHANGES. THE USER DECLINED THE ADDITIONAL EDUCATION SESSION, HOWEVER, THE CDS WAS ABLE TO REINFORCE HOW TO PREPARE A SITE, WHEN TO CHANGE THE INFUSION SET, IMPORTANCE OF NOT HAVING AIR BUBBLES IN THE CARTRIDGE, BEING DISCONNECTED FROM THE ILET WHEN FILLING THE TUBING, AND IMPORTANCE OF CHECKING FOR KETONES.

    Description of Event or Problem · 0

    ON 3/6/24 BETA BIONICS WAS NOTIFIED OF AN ILET HOSPITALIZATION FOR DIABETIC KETOACIDOSIS (DKA). THE USER'S GRANDMOTHER CALLED INTO PROVIDER DETAILS OF THE EVENT INCLUDING THAT THEY REPORTED EXPERIENCING SHORTNESS OF BREATH AND VOMITING AND WAS TREATED WITH INSULIN THROUGH AN IV. THE GRANDMOTHER AND USER BELIEVE THE EVENT WAS DUE TO A BENT INFUSION SET CANNULA. THE USER WAS USING THE CONVATEC INSET (23", 6MM) INFUSION SET. THE USER LATER REPORTED THAT THEIR BLOOD GLUCOSE (BG) WAS OVER 1,000 MG/DL WHEN THEY WERE ADMITTED TO THE HOSPITAL. THE BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) SPOKE WITH THE USER'S HEALTHCARE PROVIDER (HCP) VIA EMAIL. THE HCP STATED THAT THE USER WAS ADMITTED ON (B)(6) 2024 BUT DID NOT HAVE FURTHER INFORMATION. THE HCP BELIEVES THE USER IS NOT FOLLOWING PROPER PROTOCOL REGARDING INFUSION SITE CHANGES DUE TO THE USER REPORTING PUS COMING FROM THE SITES AFTER REMOVAL OF INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821841 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization CONVATEC INSET (23", 6MM) INFUSION SET