BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25084650 · Received May 5, 2026

    Report

    Report Number
    3019004087-2026-45731
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 5, 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 USER NOTED PERSISTENT ELEVATED BLOOD GLUCOSE AROUND 231¿235 MG/DL AFTER A RECENT SUPPLY CHANGE WHILE USING THE ILET SYSTEM; INSULIN DELIVERY WAS CONFIRMED VIA SYSTEM REPORTING, AND THE USER ELECTED TO MONITOR RATHER THAN REPLACE SUPPLIES, WITH GUIDANCE TO CHANGE SUPPLIES IF GLUCOSE ROSE WITHOUT REASON. SYMPTOMS INCLUDED HYPERGLYCEMIA WITHOUT REPORTED ASSOCIATED COMPLAINTS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED NO FINDINGS AVAILABLE AND INSUFFICIENT INFORMATION TO IDENTIFY A DEVICE PROBLEM OR IMPLICATED COMPONENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS NOT ESTABLISHED. 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
    97448 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female