BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25083392 · Received May 5, 2026

    Report

    Report Number
    3019004087-2026-45688
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    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 USER EXPERIENCED ELEVATED BLOOD GLUCOSE OF 248 MG/DL DUE TO AN INFUSION SET CONNECTION THAT WAS LOOSE AT THE CONNECTOR, AFTER WHICH TIGHTENING THE CONNECTOR CAUSED ACCUMULATED INSULIN AT THE CONNECTOR TO INFUSE, AND BLOOD GLUCOSE DECREASED TO 102 MG/DL WITHIN ABOUT AN HOUR. INSET LOT NUMBER WAS REPORTED AS 6012881 AND CONNECTOR LOT NUMBER AS 861550451. TROUBLESHOOTING AND EDUCATION WERE COMPLETED WITH NO DEVICE ALERTS OR ALARMS. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED REVIEW OF THE REPORTED USE ISSUE AND COMPLETION OF TROUBLESHOOTING AND USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED AN INCORRECTLY ATTACHED INFUSION SET CONNECTOR LEADING TO DELAYED INSULIN DELIVERY FOLLOWED BY A BOLUS OF INSULIN WHEN THE CONNECTION WAS SECURED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT USER SETUP ERROR RELATED TO THE INFUSION SET CONNECTION WAS THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437054 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female DEXCOM G7 CONTINUOUS GLUCOSE MONITOR