BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24264865 · Received February 4, 2026

    Report

    Report Number
    3019004087-2026-27057
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 4, 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 THE ILET REGISTERED A GLUCOSE VALUE OF 54 MG/DL WITHOUT ALARMS WHILE A CONCURRENT FINGERSTICK MEASURED 73 MG/DL; AN URGENT LOW SOON ALERT WAS PRESENT IN THE HISTORY, THE USER WAS INSTRUCTED TO MANUALLY ENTER THE FINGERSTICK VALUE, INGEST A SMALL AMOUNT OF CARBOHYDRATE, AND WAIT 15 MINUTES, AND PUMP LOW-GLUCOSE INSULIN SUSPENSION WAS CONFIRMED. SYMPTOMS INCLUDED NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED USER COMMUNICATION AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED A MECHANICAL PROBLEM ASSOCIATED WITH THE DEVICE FUNCTION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS MANUFACTURING DEFICIENCY. 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
    316448 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female