BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23599270 · Received November 19, 2025

    Report

    Report Number
    3019004087-2025-08669
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 4, 2024
    Report Date
    November 19, 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

    THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, PATIENT¿S SON CONTACTED SUPPORT AFTER INFUSION SET WAS ACCIDENTALLY PULLED OUT. AGENT GUIDED CAREGIVER THROUGH SUPPLY CHANGE AND INSULIN DELIVERY RESUMED. DURING TROUBLESHOOTING, PATIENT EXPERIENCED REPEATED ¿UNABLE TO PROCEED¿ ALERTS DURING TUBING FILL. AGENT INSTRUCTED PATIENT TO ATTEMPT FILL PROCESS MULTIPLE TIMES WITH EMPTY CHAMBER, THEN WITH A NEW CARTRIDGE. ISSUE RESOLVED AND INSULIN DELIVERY RESUMED SUCCESSFULLY. FOLLOW-UP ONE HOUR LATER CONFIRMED PATIENT¿S BG WAS BACK IN RANGE. PATIENT EXPRESSED INTEREST IN SWITCHING TO CONTACT DETACH INFUSION SET; AGENT ARRANGED SHIPMENT. DURING EVENT, PATIENT¿S BG REACHED 329 MG/DL AT APPROXIMATELY 5:00 AM. PATIENT USED BACKUP THERAPY TO CORRECT HIGH BG. NO KETONE TESTING PERFORMED. NO PROFESSIONAL MEDICAL INTERVENTION REQUIRED. CAREGIVER ASSISTED THROUGHOUT. NO IMMEDIATE HEALTH EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262941 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown