BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19480761 · Received June 6, 2024

    Report

    Report Number
    3019004087-2024-00176
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 5, 2024
    Report Date
    June 6, 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. DATA FOR THE DESCRIBED EVENT DATE OF 2024-05-06 WERE REVIEWED. THE HYPERGLYCEMIC EVENT BEGAN ON 2024-05-05, SO THAT DATE IS INCLUDED IN THIS LOG REVIEW. THE DEVICE WAS FIRST INITIALIZED ON 2024-02-16, AND THEN WAS RE-INITIALIZED ON 2024-05-02. NO MALFUNCTION ALERTS WERE FOUND IN THE DEVICE ENGINEERING LOGS. NO MOTOR ERRORS WERE SEEN TO INDICATE INACCURATE DOSING RELATIVE TO DELIVERY REQUESTS FOR INSULIN. NO FACTORY RESETS WERE FOUND IN THE DEVICE ENGINEERING LOGS. HOWEVER, THE DEVICE HAD TO GO THROUGH THE STARTUP PROCESS AGAIN ON 2024-05-02 AFTER BEING POWERED OFF SINCE 2024-03-16. BODY WEIGHT WAS DECREASED BY TWO POUNDS WHEN THE USER STARTED THE ILET ON 2024-05-02 COMPARED TO WHEN THE ILET WAS FIRST STARTED ON 2024-02-16. AUDIO SETTING AND CGM ALERT SETTINGS WERE NOT CHANGED FROM INITIAL SET UP (HIGH/ON). THE LAST CARTRIDGE AND INFUSION SET CHANGE PRIOR TO THE EVENT DATE WERE LOGGED ON 2024-05-02 AT 6:00 PM. THE CARTRIDGE WAS CHANGED AGAIN ON 2024-05-05 AT 1:17 PM, BUT AN INFUSION SET CHANGE WAS NOT LOGGED AT THAT TIME. THE LAST DEXCOM G7 CGM SENSOR CHANGE PRIOR TO THE EVENT DATE WAS LOGGED ON 2024-05-02. MULTIPLE MEALS WERE ANNOUNCED DURING THE HYPERGLYCEMIC PERIOD ON 2024-05-05 AND 2024-05-06. DEVICE DATA ENDS ON 2024-05-06 AT 7:44 AM WHEN THE DEVICE IS POWERED OFF. THE DEVICE IS NOT TURNED BACK ON AGAIN UNTIL THE FOLLOWING DAY. REVIEW OF THE ILET REPORT SHOWS CGM GLUCOSE WAS IN RANGE UNTIL 1:42 PM, WHEN IT WENT ABOVE RANGE AND STAYED THERE UNTIL THE DEVICE WAS POWERED OFF. DURING THIS TIME, THE ILET WAS DOSING INSULIN IN RESPONSE TO CGM GLUCOSE VALUES AND USER-INITIATED MEAL ANNOUNCEMENTS. 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. 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 REVIEW OF THE CASE NOTES, ILET REPORT, AND DEVICE LOGS, THE ILET OPERATED AS INTENDED THROUGHOUT THIS EVENT BY DELIVERING INSULIN AND TRIGGERING ALERTS IN RESPONSE TO ELEVATED CGM GLUCOSE VALUES. THE ASSIGNABLE CAUSES FOR THIS HYPERGLYCEMIC EVENT ARE POSSIBLY A FAILURE WITH THE SUPPLY CHANGE THAT WAS DONE, OR A FAILED INFUSION SET, EVEN THOUGH THERE IS NO INFUSION SET CHANGE LOGGED IN THE DEVICE FOR THE DATE OF THE EVENT. THE USER MAY HAVE REPLACED THEIR INFUSION SET AT THE TIME THEY REPLACED THE CARTRIDGE AND DID NOT COMPLETE THE PROCESS ON THE DEVICE, AND IT WAS THIS NEW SITE THAT FAILED. ALTERNATIVELY, THE SITE MAY HAVE FAILED BECAUSE THEY DIDN'T REPLACE IT AFTER IT HAD BEEN IN FOR MORE THAN THREE DAYS. HOWEVER, WITHOUT ADDITIONAL INFORMATION FROM THE USER, IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT CAUSED THIS EVENT.

    Description of Event or Problem · 0

    ON 5/7/24 A BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) WAS NOTIFIED BY A HEALTHCARE PROVIDER (HCP) THAT AN ILET USER EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT RESULTING IN DIABETIC KETOACIDOSIS (DKA). THE EXACT EVENT DATE WAS NOT REPORTED BUT IS ESTIMATED TO BE (B)(6) 2024 - (B)(6) 2024. THE HCP REPORTED THE USER HAS "GONE INTO DKA EACH TIME THEY STARTED WEARING THE ILET." MULTIPLE ATTEMPTS BY BETA BIONICS CUSTOMER CARE TO CONTACT THE USER FOR ADDITIONAL EVENT INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100421 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization