BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS - TA000021-001

    MDR report key: 22786162 · Received August 12, 2025

    Report

    Report Number
    3019004087-2025-00870
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K223846
    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¿S MOTHER REPORTED THAT THE DEVICE'S SCREEN HAD A VISIBLE WHITE LINE ALONG THE LEFT EDGE. THE SCREEN REMAINED RESPONSIVE HOWEVER PHYSICAL DISPLAY DAMAGE WAS CONFIRMED. DEVICE WILL BE REPLACED. BLOOD GLUCOSE WAS NOT AFFECTED. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258662 ILET BIONIC PANCREAS - TA000021-001 ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXCOM G7 CONTINUOUS GLUCOSE MONITOR