BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23550290 · Received November 13, 2025

    Report

    Report Number
    3019004087-2025-07938
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    November 13, 2025
    Report Date
    November 13, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ILET BECAME WET WHILE THE USER WAS IN A POOL OR SPA AREA, AFTER WHICH THE DEVICE WOULD NOT POWER ON AND THE SCREEN WAS NONFUNCTIONAL; THE USER ATTEMPTED TO CHARGE THE DEVICE WITHOUT SUCCESS AND WILL RETURN THE DEVICE. SYMPTOMS INCLUDED NO REPORTED INJURY AND NO REPORTED ADVERSE CLINICAL EFFECTS, WITH BLOOD GLUCOSE REPORTEDLY UNAFFECTED AND BACKUP THERAPY IN USE. OUTCOMES INCLUDED INTERRUPTION OF DEVICE FUNCTION WITHOUT CLINICAL IMPACT OR MEDICAL INTERVENTION. INVESTIGATION INCLUDED A REVIEW OF THE REPORTED EVENT AND PREPARATION FOR DEVICE EVALUATION UPON RETURN. INVESTIGATION OF THIS CASE REVEALED DEVICE EXPOSURE TO LIQUID WITH RESULTANT FAILURE TO POWER ON AND LOSS OF DISPLAY FUNCTION. IT WAS CONCLUDED THAT LIQUID INTRUSION LED TO DEVICE MALFUNCTION WITH NO ASSOCIATED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882579 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female