BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24867722 · Received April 13, 2026

    Report

    Report Number
    3019004087-2026-42433
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 13, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A USER EXPERIENCED A LOW GLUCOSE ALERT ON THE ILET AFTER DISCONNECTING FOR A SHOWER AND SUBSEQUENTLY RECONNECTING, WITH A NADIR OF 55 MG/DL; THE USER TREATED WITH ORAL GLUCOSE, LATER ATE A MEAL, CONFIRMED RECOVERY TO 110¿116 MG/DL BY FINGERSTICK, AND REPLACED THE INFUSION SET AND INSULIN CARTRIDGE. SYMPTOMS INCLUDED HYPOGLYCEMIA. OUTCOMES INCLUDED RESOLUTION OF THE LOW GLUCOSE FOLLOWING ORAL CARBOHYDRATE AND CONTINUED MONITORING AT HOME WITHOUT HOSPITALIZATION. INVESTIGATION INCLUDED USER INTERVIEW AND TROUBLESHOOTING WITH EDUCATION ON HYPOGLYCEMIA MANAGEMENT AND INFUSION SET REPLACEMENT. INVESTIGATION OF THIS CASE REVEALED NO DEVICE MALFUNCTION IDENTIFIED, WITH THE EVENT OCCURRING AFTER A TEMPORARY DISCONNECTION AND RESOLVING WITH STANDARD TREATMENT AND SET CHANGE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. 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
    101015 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention