BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23179615 · Received September 30, 2025

    Report

    Report Number
    3019004087-2025-03850
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE USER REPORTED HIGH BLOOD GLUCOSE (BG), WITH A HIGH BLOOD GLUCOSE (BG) OF 400 MG/DL. AFTER AN "OCCLUSION ALERT", THE ISSUE WAS RESOLVED, AND INSULIN DELIVERY RESUMED. BLOOD GLUCOSE (BG) DECREASED TO 307 MG/DL BUT REMAINED AT THAT LEVEL FOR APPROXIMATELY TWO HOURS. THE AGENT ADVISED THAT IF BLOOD GLUCOSE (BG) DID NOT CONTINUE TO DECLINE, A SUPPLY CHANGE MIGHT BE NECESSARY. BLOOD GLUCOSE (BG) WAS CORRECTED WITH INSULIN DELIVERED BY THE ILET. THE USER REFUSED FURTHER FOLLOW UP. NO SYMPTOMS WERE REPORTED DURING THE EVENT, AND NO OUTSIDE ASSISTANCE, OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013814 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male