BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24576714 · Received March 12, 2026

    Report

    Report Number
    3019004087-2026-37294
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER EXPERIENCED AN ALERT 38 MOTOR STALL DURING A SUPPLY CHANGE, WAS UNABLE TO PROCEED, AND CONTINUED TO RECEIVE THE ERROR AFTER RESTARTING THE ILET; A DRY RUN SUCCEEDED, AND A SUBSEQUENT ATTEMPT WITH A NEW SUPPLY SET COMPLETED SUCCESSFULLY, WITH THE REPORTED LOT NUMBER 6012870; A REPLACEMENT BELT CLIP WAS ALSO REQUESTED DUE TO LOSS. SYMPTOMS INCLUDED NO REPORTED CLINICAL EFFECTS. OUTCOMES INCLUDED NO IMPACT TO HEALTH AND NO HOSPITALIZATION. INVESTIGATION INCLUDED CUSTOMER SUPPORT TROUBLESHOOTING, DEVICE RESTART, A DRY RUN, AND REATTEMPT WITH A NEW SUPPLY SET. INVESTIGATION OF THIS CASE REVEALED THAT THE CONSECUTIVE MOTOR STALL RESOLVED AFTER REPLACING THE SUPPLY SET, INDICATING A SUPPLY SET OR CONSUMABLE-RELATED OBSTRUCTION RATHER THAN AN INTERNAL PUMP MOTOR FAILURE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER OR USE-RELATED FACTORS ASSOCIATED WITH THE SUPPLY SET RATHER THAN A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640054 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown