BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25176772 · Received May 14, 2026

    Report

    Report Number
    3019004087-2026-47203
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 14, 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 USER EXPERIENCED SUSTAINED HIGH BLOOD GLUCOSE AND LATER DISCLOSED DEPLOYING FOUR INFUSION SETS FROM LOT # 6011166 INCORRECTLY BY FAILING TO REMOVE THE NEEDLE COVER, WHICH LIKELY PREVENTED PROPER INSULIN DELIVERY. REPLACEMENT SUPPLIES WERE SHIPPED AFTER ADDRESS CONFIRMATION. SYMPTOMS INCLUDED HYPERGLYCEMIA WITH A REPORTED REACHING ABOVE 400 MG/DL. OUTCOMES INCLUDED NO HOSPITALIZATION, NO MANUAL INSULIN INJECTIONS, AND RELIANCE ON THE ILET TO CORRECT GLUCOSE. INVESTIGATION INCLUDED REVIEW OF USER REPORT AND TROUBLESHOOTING CONSISTENT WITH INFUSION SET USE ERROR. INVESTIGATION OF THIS CASE REVEALED THAT INFUSION SET DEPLOYMENT ERRORS, AND AN UNSECURED OR OBSTRUCTED INFUSION SET CONNECTION WERE CONSISTENT WITH INTERRUPTED INSULIN DELIVERY. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER ERROR RELATED TO INFUSION SET HANDLING AND ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520756 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1