BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22889905 · Received August 25, 2025

    Report

    Report Number
    3019004087-2025-01359
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 27, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    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

    IT WAS REPORTED THAT A BETA BIONICS ILET USER'S ILET FELL OFF THE CHARGER YESTERDAY, AND THE SCREEN CRACKED. THE USER HAS BEEN WEARING THE ILET BUT NEEDS A NEW ONE SINCE IT IS NOT WATERTIGHT. A REPLACEMENT WAS ARRANGED. THERE WAS NO REPORT OF ANY PATIENT HARM OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578130 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female