BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25258620 · Received May 22, 2026

    Report

    Report Number
    3019004087-2026-48284
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 22, 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

    Additional Manufacturer Narrative · 0

    INITIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE ILET, THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE OF 183¿187 MG/DL AFTER EATING A SNACK WITHOUT MAKING A MEAL ANNOUNCEMENT; THE USER HAD RECENTLY CHANGED THE INFUSION SITE AND THE AGENT ADVISED ALLOWING TIME FOR THE PUMP TO CORRECT, WITH NO ALERTS OR ALARMS REPORTED. NO ADVERSE CLINICAL SYMPTOMS ASSOCIATED WITH HYPERGLYCEMIA REPORTED. OUTCOMES INCLUDED A MINOR, NON-SERIOUS IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF THE INFORMATION PROVIDED. INVESTIGATION OF THIS CASE REVEALED NO DEVICE PROBLEM AND IDENTIFIED A USAGE ISSUE RELATED TO AN IMPROPER OR INCORRECT PROCEDURE, SPECIFICALLY FAILURE TO FOLLOW INSTRUCTIONS FOR ANNOUNCING A MEAL VIA THE USER INTERFACE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS FAILURE TO FOLLOW INSTRUCTIONS AND AN UNINTENDED USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267769 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1