BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25009703 · Received April 27, 2026

    Report

    Report Number
    3019004087-2026-44289
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    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 THE ILET USER EXPERIENCED RECURRENT CYCLES OF HYPOGLYCEMIA AND HYPERGLYCEMIA, ASSOCIATED WITH MISSED MEAL ANNOUNCEMENTS. THE USER WOULD EAT WITHOUT ANNOUNCING, GLUCOSE WOULD RISE TO APPROXIMATELY 250¿401 MG/DL, THEN FALL TO 35¿50 MG/DL, AND A FACTORY RESET AND ADDITIONAL TRAINING WERE PROVIDED. SYMPTOMS INCLUDED HYPOGLYCEMIA, HYPERGLYCEMIA, DIAPHORESIS, DIZZINESS, MALAISE, SHAKING/TREMORS, AND MUSCLE WEAKNESS. OUTCOMES INCLUDED SERIOUS INJURY LEADING TO UNEXPECTED MEDICAL INTERVENTION WITH ORAL GLUCOSE. INVESTIGATION INCLUDED INTERVIEWS AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED NO DEVICE PROBLEM, AND A USAGE PROBLEM RELATED TO MISSED MEAL ANNOUNCEMENTS. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS FAILURE TO FOLLOW INSTRUCTIONS AND AN UNINTENDED USE ERROR THAT CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444002 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.