BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24450495 · Received February 25, 2026

    Report

    Report Number
    3019004087-2026-33258
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 22, 2026
    Report Date
    February 25, 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 A CAREGIVER EXPERIENCED DIFFICULTY PAIRING A DEXCOM G7 SENSOR TO THE ILET, WITH A SENSOR WARMUP DISPLAYED ON THE G7 APP BUT NOT ON THE PUMP; THE AGENT INSTRUCTED TOGGLING BETWEEN G6 AND G7, RESTARTING THE PUMP, AND RE-ENTERING THE PAIRING CODE, AFTER WHICH THE CAREGIVER WAS ADVISED TO WAIT FOR READINGS. SYMPTOMS INCLUDED NO ALERTS OR ALARMS AND NO REPORTED ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED NO INJURY AND NO HOSPITALIZATION. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION REGARDING SENSOR SELECTION, DEVICE RESTART, AND CODE RE-ENTRY. INVESTIGATION OF THIS CASE REVEALED A PAIRING FAILURE BETWEEN THE G7 SENSOR AND THE ILET THAT WAS ADDRESSED THROUGH SOFTWARE SETTINGS VERIFICATION AND REINITIALIZATION STEPS, WITH NO TRANSMITTER IN USE AND NO DEVICE ALARM BEHAVIOR OBSERVED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER SETUP ERROR RELATED TO SENSOR CONFIGURATION AND PAIRING WORKFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372412 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown