BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 18915202 · Received March 15, 2024

    Report

    Report Number
    3019004087-2024-00050
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    January 27, 2024
    Report Date
    March 15, 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

    THE ILET LOGS COULD NOT BE REVIEWED AS THE AVAILABLE DATA ENDS BEFORE THE DESCRIBED EVENT DATE. THE USER HAS REQUESTED TO RETURN THE DEVICE AND IS NO LONGER ABLE TO SYNC DEVICE LOGS. THE DEVICE HAS YET TO BE RETURNED TO BETA BIONICS. AS A RESULT, THE COMPLAINT CANNOT BE EVALUATED AT THIS TIME. IF THE PRODUCT IS RECEIVED AT A LATER DATE, OR THE ILET ENGINEERING LOGS FOR THE DESCRIBED EVENT BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED AND INVESTIGATED ACCORDINGLY. 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 LIMITED INFORMATION PROVIDED BY THE USER AND THE ABSENCE OF DATA SPECIFIC TO THE REPORTED EVENT DATE, WE ARE UNABLE TO DETERMINE AN ASSIGNABLE CAUSE. HOWEVER, REVIEW OF AVAILABLE DATA FROM THE ILET REPORT FOR THE WEEK PRIOR SUGGESTS THAT THE USER MAY NOT HAVE BEEN WEARING THE ILET AT THE TIME OF THE EVENT. THIS IS BASED ON THE ABSENCE OF INSULIN DOSING AND MEAL ANNOUNCEMENTS ON THE REPORT GRAPH, YET THE CGM GLUCOSE AND TARGET ARE STILL DISPLAYED. THE USER'S CGM TREND SHOWS THE GLUCOSE COMING BACK INTO RANGE AFTER PERIODS OF HYPERGLYCEMIA WITH NO INSULIN DOSING BY THE ILET LOGGED ON THE GRAPH. REVIEW OF THE AVAILABLE LOGS SHOWS THE ILET ALERTED THE USER THAT THE INSULIN CARTRIDGE WAS EMPTY ON 2024-01-19 AT 11:54 PM, BUT THE ALERT WAS NEVER ACKNOWLEDGED, AND THE CARTRIDGE CHANGE PROCESS WAS NOT COMPLETED. THIS INDICATES THAT THE USER WAS NOT WEARING THE ILET AND HAD SWITCHED TO AN ALTERNATIVE THERAPY, BUT THE ILET WAS STILL READING THEIR CGM AND WAS UNABLE TO DOSE INSULIN.

    Description of Event or Problem · 0

    ON 2/16/24 AN ILET USER REPORTED THEY WERE HOSPITALIZED ON (B)(6) 2024 DUE TO A HIGH BLOOD GLUCOSE (BG) EVENT. THE USER REPORTED THEIR BG ROSE TO 595 MG/DL AND RESULTED IN AN ER VISIT. THE USER DOES NOT RECALL IF THERE WERE ANY ALERTS OR MALFUNCTIONS SHOWN ON THE ILET AND IS UNSURE OF WHAT CAUSED THE HYPERGLYCEMIA. THEY DID NOT TEST FOR KETONES AND DO NOT RECALL IF THEY WERE IN DIABETIC KETOACIDOSIS (DKA). THEY REPORTED RECEIVING INSULIN AND AN IV AS WELL AS BEING RELEASED FROM THE ER ON THE SAME DAY. THE USER DECIDED TO DISCONTINUE USE OF THE ILET AND REQUESTED TO RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966458 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