BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24292377 · Received February 9, 2026

    Report

    Report Number
    3019004087-2026-28050
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 9, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED BEYOND THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYS ASSOCIATED WITH RECENT INTERNAL SYSTEM CHANGES. THE DELAY WAS UNINTENTIONAL AND HAS SINCE BEEN ADDRESSED THROUGH PROCESS AND SYSTEM UPDATES TO PREVENT RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER RECEIVED AN INSULIN SET EXPIRATION ALERT DESPITE HAVING CHANGED THE SET THE PRIOR DAY AND LATER EXPERIENCED ELEVATED BLOOD GLUCOSE WHILE USING THE ILET SYSTEM. SYMPTOMS INCLUDED HYPERGLYCEMIA WITH READINGS AROUND 230¿245 MG/DL WITHOUT ACUTE DISTRESS. OUTCOMES INCLUDED REMOTE TROUBLESHOOTING, USER EDUCATION ON DISMISSING THE EXPIRATION ALERT, GUIDANCE ON PAUSING AND DISCONNECTING FOR SHOWERING, SYNCHRONIZATION OF REPORTS, AND VERIFICATION THAT SMALL CORRECTIVE DOSES WERE BEING DELIVERED. INVESTIGATION INCLUDED REVIEW OF UPLOADED DEVICE DATA AND ASSESSMENT OF DOSING ACTIVITY RELATIVE TO THE ANNOUNCED MEAL. INVESTIGATION OF THIS CASE REVEALED NO DEVICE MALFUNCTION, WITH THE ELEVATION ATTRIBUTED TO A LARGER-THAN-USUAL MEAL AND EARLY ACCLIMATION TO THE ILET, WHILE THE SET-EXPIRATION ALERT WAS ADDRESSED THROUGH USER ACTION WITHOUT RECURRENCE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR BUT CONSISTENT WITH USER-SPECIFIC FACTORS AND NORMAL ALGORITHMIC RESPONSE DURING ADAPTATION. 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
    353059 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown