BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24193863 · Received January 27, 2026

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    Report

    Report Number
    3019004087-2026-24835
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    February 13, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BB1001.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER THE INFUSION SET CONNECTION WAS NOT FULLY TIGHTENED AT THE LUER CONNECTOR, LEADING TO IMPAIRED INSULIN DELIVERY; THE CAREGIVER NOTED THE DEXCOM G7 WAS READING INACCURATELY AND PERFORMED A CALIBRATION, AND EDUCATION WAS PROVIDED ON PROPER USE OF THE 23 IN 6 MM INSET FOR THREE DAYS AND ASSOCIATED SUPPLIES. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE CONFIRMED BY FINGERSTICK AT 236 MG/DL WITHOUT OTHER ACUTE SYMPTOMS. OUTCOMES INCLUDED NO USE OF BACKUP THERAPY, NO KETONE TESTING, NO MEDICAL INTERVENTION, AND RESOLUTION AFTER SECURING THE LUER CONNECTOR. INVESTIGATION INCLUDED CUSTOMER INTERVIEW AND TROUBLESHOOTING WITH USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED AN INCORRECTLY SECURED INFUSION SET CONNECTOR CAUSING UNDER-DELIVERY, CONSISTENT WITH AN INFUSION SET AND CARTRIDGE HANDLING ISSUE AT THE LUER CONNECTION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER TECHNIQUE RELATED TO INFUSION SET CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248583 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other