BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25311241 · Received May 27, 2026

    Report

    Report Number
    3019004087-2026-48813
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 27, 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 DURING ILET SETUP TRAINING, AN INFUSION SET FELL OUT OF THE INSERTER WHILE THE USER UNWOUND THE TUBING, CAUSING THE SET TO COME OFF THE CENTER TRACK AND PREVENTING PROPER DEPLOYMENT; THE EVENT WAS CATEGORIZED AS AN INFUSION SET DEPLOYED INCORRECTLY, ASSOCIATED WITH THE INFUSION SET FROM LOT NUMBER 6012881. THERE WERE NO REPORTED SYMPTOMS, ADVERSE CLINICAL EFFECTS, ALERTS, OR ALARMS. OUTCOMES INCLUDED SHIPMENT OF REPLACEMENT SUPPLIES AND COMPLETION OF TROUBLESHOOTING AND EDUCATION. INVESTIGATION INCLUDED USER COACHING ON CORRECT HANDLING AND INSERTION TECHNIQUE. INVESTIGATION OF THIS CASE REVEALED USER HANDLING DURING TUBING UNWINDING LIKELY DISPLACED THE SET FROM THE INSERTER TRACK, RESULTING IN AN INSERTION FAILURE CONSISTENT WITH PREVIOUSLY OBSERVED USE-RELATED ISSUES. IT WAS CONCLUDED, BASED ON ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER TECHNIQUE AND USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308696 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1