BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 19812326 · Received July 23, 2024

    Report

    Report Number
    3019004087-2024-00281
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 23, 2024
    Report Date
    July 23, 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 EVIDENCE OF DEVICE MALFUNCTION WAS FOUND IN THE ENGINEERING LOGS. DEVICE DATA CONFIRMED HYPERGLYCEMIA ON THE REPORTED EVENT DATE, BEGINNING ON 2024-06-21. THE ILET WAS BEHAVING AS INTENDED AND CAN BE SEEN REACTING APPROPRIATELY TO CGM GLUCOSE VALUES WHEN IT WAS ABLE, ASIDE FROM PROLONGED PERIODS ON 2024-06-21, 2024-06-22, AND 2024-06-23 WHEN THE ILET WAS UNABLE TO DOSE INSULIN DUE TO THE CARTRIDGE RUNNING OUT OF INSULIN AND NOT BEING REPLACED PROMPTLY. 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 THE CASE NOTES AND THE DEVICE DATA, THE ILET OPERATED AS INTENDED. THIS HYPERGLYCEMIC EVENT WAS CAUSED BY A FAILURE TO MAINTAIN THE DEVICE TO ENSURE CONTINUOUS INSULIN DELIVERY BY NOT REPLACING THE INSULIN CARTRIDGE WHEN IT WAS EMPTY, AS WELL AS A FAILURE TO FOLLOW THE KETONE ACTION PLAN.

    Description of Event or Problem · 0

    ON 6/23/24 A BETA BIONICS CLINICAL DIABETES SPECIALIST (CDS) WAS MADE AWARE THAT AN ILET USER EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT RESULTING IN DIABETIC KETOACIDOSIS (DKA) AND HOSPITALIZATION. THE EVENT OCCURRED ON 6/23/24. ON 6/22/24 THE USER REPORTED THEY WERE AT A FAMILY BBQ WHERE THEY HAD HIGH BG LEVELS AND WERE UNABLE TO MANAGE THEIR DIABETES DUE TO A LACK OF SUPPLIES AND INSULIN. BY THE EVENING, THE USER'S ILET BATTERY DIED, AND THEY FELL ASLEEP AWAY FROM THEIR DEVICES, MISSING ALERTS. THE NEXT MORNING (6/23/24), AFTER PLACING A NEW INFUSION SET, THE USER VOMITED SEVERAL TIMES AND EXPERIENCED EXTREMELY HIGH BG LEVELS (>400 MG/DL). LARGE KETONES WERE DETECTED IN THEIR URINE. THE USER FOLLOWED THE KETONE ACTION PLAN (KAP) BUT, DUE TO WORSENING CONDITIONS, WAS DRIVEN TO THE HOSPITAL WHERE THEY WERE ADMITTED TO THE ICU. THE TREATMENT INCLUDED IV INSULIN, POTASSIUM, AND NAUSEA MEDICATION. THE USER WAS RELEASED ON 6/26/24 AND IS NOW BACK ON THE ILET. IMMEDIATE EFFECTS INCLUDED DKA, LOSS OF CONSCIOUSNESS, AND NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482959 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