BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25222015 · Received May 19, 2026

    Report

    Report Number
    3019004087-2026-47731
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    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 AN ILET USER EXPERIENCED PERSISTENT ELEVATED BLOOD GLUCOSE READINGS AROUND 220¿231 MG/DL AFTER LUNCH DESPITE ANNOUNCING THE MEAL, PERFORMING A SITE CHANGE TO THE LEFT ABDOMEN, AND CONFIRMING NO VISIBLE ISSUES WITH SUPPLIES; THE EVENT WAS CATEGORIZED AS HYPERGLYCEMIA WITH THE CAUSE UNCLEAR. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED USER COMMUNICATION AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED NO FINDINGS AVAILABLE, WITH INSUFFICIENT INFORMATION TO IDENTIFY A MEDICAL DEVICE PROBLEM OR A SPECIFIC DEVICE COMPONENT INVOLVED. 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
    499064 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1