BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25119963 · Received May 8, 2026

    Report

    Report Number
    3019004087-2026-46347
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 7, 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 EXPERIENCED PERSISTENT HYPERGLYCEMIA WHILE USING THE ILET WITH MULTIPLE INFUSION SET CHANGES OVER TWO DAYS, NOTING EACH CANNULA APPEARED STRAIGHT AND NORMAL AND THAT ALL AFFECTED SETS CAME FROM THE SAME BOX (LOT 6011164). SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE, WITH A REPORTED VALUE OF 252 MG/DL, AND NO OTHER SYMPTOMS. OUTCOMES INCLUDED THE USER¿S DECISION TO DISCONTINUE PUMP INSULIN DELIVERY TEMPORARILY AND USE MULTIPLE DAILY INJECTIONS UNTIL REPLACEMENT SUPPLIES ARRIVE. INVESTIGATION INCLUDED TROUBLESHOOTING EDUCATION, CONFIRMATION OF CORRECT INSERTION TECHNIQUE AND SUPPLY CHANGE PROCESS, REVIEW OF POTENTIAL SITE ISSUES, AND ISSUANCE OF REPLACEMENT INFUSION SETS AS A GOODWILL MEASURE. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS OR MALFUNCTIONS AND SUGGESTED A POTENTIAL SUPPLY ISSUE CONFINED TO A SINGLE BOX, WITH HYPERGLYCEMIA CAUSE REMAINING UNCLEAR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNDETERMINED. 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
    245100 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male