BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 20714216 · Received November 18, 2024

    Report

    Report Number
    3019004087-2024-00604
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 20, 2024
    Report Date
    November 18, 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 THAT BEGAN FOLLOWING A SUPPLY CHANGE. 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 CASE NOTES AND DEVICE DATA, THE ILET OPERATED AS INTENDED. THIS HYPERGLYCEMIC EVENT WAS CAUSED BY A FAILED INFUSION SET RESULTING IN INSUFFICIENT INSULIN DELIVERY.

    Description of Event or Problem · 0

    ON 10/20/24 BETA BIONICS CHIEF MEDICAL OFFICER (CMO) WAS MADE AWARE THAT AN ILET USER EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT RESULTING IN HOSPITALIZATION. THE EVENT OCCURRED ON 10/20/24. THE CMO REPORTED THE USER WAS ADMITTED TO MASSACHUSETTS GENERAL HOSPITAL (MGH) WITH HYPERGLYCEMIA AND KETOSIS DUE TO A FAILURE OF THEIR CONVATEC INSET (23", 6MM) TEFLON INFUSION SET. ALTHOUGH THEIR PH WAS WITHIN THE NORMAL RANGE, THEY HAD AN ANION GAP AND KETONES, AND THEIR CONDITION DID NOT TECHNICALLY MEET THE CRITERIA FOR DIABETIC KETOACIDOSIS (DKA). THE FAILURE OCCURRED AFTER A NIGHT OF HEAVY ALCOHOL CONSUMPTION (4 BEERS, AND ENTIRE BOTTLE OF LIQUOR), WHICH MAY HAVE CONTRIBUTED TO THE USER'S VOMITING. THE USER NOTICED THAT THEIR INFUSION SET DRESSING WAS WET AND SMELLED OF INSULIN BUT DID NOT REPLACE THE SET, NOT REALIZING THE SIGNIFICANCE OF THESE SIGNS. THE USER ATTEMPTED TO ANNOUNCE A FAKE MEAL, BUT IT WAS INEFFECTIVE, AND THEY WERE TREATED WITH AN INSULIN INFUSION UPON ARRIVING AT THE EMERGENCY DEPARTMENT, WHERE THEIR KETOSIS RESOLVED QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620533 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 CONVATEC INSET (23", 6MM) TEFLON INFUSION SET| DEXCOM G7 CONTINUOUS GLUCOSE MONITOR