BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24027637 · Received January 9, 2026

    Report

    Report Number
    3019004087-2026-20793
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 9, 2026
    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 AN INSET INFUSION SET WAS DEPLOYED INCORRECTLY AND ANOTHER INFUSION SET WAS CRIMPED OUT OF THE BOX (CAPTURED IN (B)(4) / CASE NUMBER (B)(4)), LEADING TO DIFFICULTY ATTACHING OR USING THE INFUSION SET AND A REQUEST FOR REPLACEMENT SUPPLIES. NO REPORTED SYMPTOMS. OUTCOMES INCLUDED NO ALERTS OR ALARMS AND REPLACEMENT INFUSION SETS SHIPPED WITH TROUBLESHOOTING AND EDUCATION PROVIDED. INVESTIGATION INCLUDED CASE DOCUMENTATION REVIEW AND ASSESSMENT OF USER HANDLING AND INFUSION SET DEPLOYMENT. INVESTIGATION OF THIS CASE REVEALED USER-RELATED INSERTION ERROR CONSISTENT WITH A DEPLOYMENT ISSUE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USE ERROR DURING INFUSION SET DEPLOYMENT WITH A POSSIBLY DAMAGED INFUSION SET FROM THE LOT PROVIDED (6010685).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90519 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.