BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22639072 · Received July 28, 2025

    Report

    Report Number
    3019004087-2025-00697
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BETA BIONICS
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE USER WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) AND A REPORTED BLOOD GLUCOSE (BG) LEVEL OVER 900MG/DL. THE USER'S DEXCOM G7 SENSOR HAD FAILED AND WAS NOT REPLACED, RESULTING IN A LOSS OF CGM CONNECTIVITY. THE USER WAS UNAWARE THAT DOSING HAD STOPPED DUE TO BG RUN MODE. NO HIGH GLUCOSE ALERTS WERE RECEIVED. AFTER APPROXIMATELY SIX HOURS OF SYMPTOMS, THE USER'S DAUGHTER CALLED EMERGENCY SERVICES. THE USER WAS ADMITTED TO THE ICU AND TREATED WITH INTRAVENOUS INSULIN. THE USER WAS DISCHARGED ON (B)(6) 2025, RECEIVED LONG-ACTING INSULIN, AND WAS INSTRUCTED TO DELAY ILET RECONNECTION. THE USER PLANNED TO CONTINUE MDI THERAPY TEMPORARILY AND RECEIVED ADDITIONAL TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622772 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| O DEXCOM G7 CONTINUOUS GLUCOSE MONITOR