BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24210650 · Received January 29, 2026

    Report

    Report Number
    3019004087-2026-25366
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    June 15, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A USER EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS BEGINNING AFTER A SUPPLY CHANGE, WITH SENSOR VALUES IN THE HIGH 200S MG/DL AND A CONFIRMATORY FINGERSTICK OF 207 MG/DL; NO SITE ISSUES WERE VISIBLE, THE USER PERFORMED ANOTHER SUPPLY CHANGE WITH LOT 6012521, AND GLUCOSE BEGAN TRENDING DOWN TO 231 MG/DL WITH A HORIZONTAL TREND ARROW WHILE ADVISED TO HYDRATE AND CONTINUE MONITORING. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HOSPITALIZATION, NO EMERGENCY TREATMENT, AND NO ALERTS OR ALARMS. INVESTIGATION INCLUDED CUSTOMER COUNSELING, REVIEW OF USE CONDITIONS, AND GUIDED TROUBLESHOOTING WITH A REPEAT SUPPLY CHANGE. INVESTIGATION OF THIS CASE REVEALED AN UNCLEAR CAUSE OF HYPERGLYCEMIA, WITH NO DEVICE ALARMS AND NO OBSERVABLE SITE ISSUES TO IMPLICATE A SPECIFIC COMPONENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNDETERMINED. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271082 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown