BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25126536 · Received May 8, 2026

    Report

    Report Number
    3019004087-2026-46422
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 8, 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

    Additional Manufacturer Narrative · 0

    INITIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE OF 332 WHILE USING THE ILET SYSTEM, WITHOUT PRIOR FOOD INTAKE, ALARMS, OR VISIBLE SITE LEAKAGE; THE CAREGIVER SUSPECTED THE INFUSION SITE MAY HAVE BEEN TUGGED DURING A SHOWER, DROPS WERE OBSERVED WHEN THE SET WAS UNCLIPPED, AND A SITE CHANGE WAS COMPLETED, AFTER WHICH THE REMOVED CANNULA APPEARED STRAIGHT; LOT NUMBER 6011166 WAS PROVIDED. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED USER TROUBLESHOOTING AND EDUCATION WITH SUCCESSFUL COMPLETION OF A SITE CHANGE. INVESTIGATION INCLUDED GUIDED ASSESSMENT OF THE INFUSION SITE FOR LEAKAGE AND REPLACEMENT OF THE INFUSION SET. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS AND POTENTIAL INFUSION DISRUPTION AT THE SITE, CONSISTENT WITH UNEXPLAINED HYPERGLYCEMIA AND A POSSIBLE INFUSION ISSUE DESPITE A STRAIGHT CANNULA. 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
    49790 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1