BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24004159 · Received January 8, 2026

    Report

    Report Number
    3019004087-2026-20303
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    November 13, 2024
    Report Date
    January 8, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LONG-TERM ILET USER EXPERIENCED HYPERGLYCEMIA WITH CGM READINGS IN THE 200¿296 MG/DL RANGE FOR APPROXIMATELY FIVE HOURS AFTER DINNER, ALONGSIDE A RECENT A1C INCREASE FROM 6.8 TO 7.6, AND EXPRESSED CONCERN THAT THE ALGORITHM HAD MALADAPTED; THE USER ACKNOWLEDGED OCCASIONAL MIS-ANNOUNCEMENTS AND HAS BEEN PREEMPTIVELY CORRECTING WHEN GLUCOSE IS IN THE 80S¿90S, AND THEY USE A DEXCOM G7. SYMPTOMS INCLUDED HYPERGLYCEMIA WITHOUT ACUTE COMPLICATIONS. OUTCOMES INCLUDED NO HOSPITALIZATION, NO PROFESSIONAL MEDICAL INTERVENTION, NO KETONE TESTING, AND NO USE OF BACKUP THERAPY. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION REGARDING THE IMPACT OF PREEMPTIVE CORRECTIONS AND MIS-ANNOUNCEMENTS ON AUTOMATED INSULIN DELIVERY. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS OR HARDWARE MALFUNCTIONS AND SUGGESTED THAT USER BEHAVIOR, INCLUDING PREEMPTIVE CORRECTION AND MIS-ANNOUNCEMENTS, COULD CONTRIBUTE TO INCREASED INSULIN DELIVERY PATTERNS AND TIME OUT OF RANGE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. 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
    67293 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Required Intervention