BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24104598 · Received January 16, 2026

    Report

    Report Number
    3019004087-2026-22469
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED, INCLUDING REVIEW OF AVAILABLE DEVICE AND CGM DATA. NO DEVICE MALFUNCTION ALERTS WERE IDENTIFIED IN THE ENGINEERING LOGS, AND INSULIN DELIVERY BEHAVIOR WAS CONSISTENT WITH EXPECTED DEVICE OPERATION BASED ON AVAILABLE INFORMATION. IT WAS CONCLUDED THAT THE EVENT WAS ASSOCIATED WITH INADEQUATE INSULIN DELIVERY OR ABSORPTION FOLLOWING A SUPPLY CHANGE, WITH NO CONFIRMED DEVICE MALFUNCTION IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; IF THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A CARTRIDGE AND SUPPLY CHANGE, THE USER¿S ILET ISSUED LOW INSULIN AND CHANGE INSULIN ALERTS, THE CARTRIDGE WAS DEPLETED, AND BLOOD GLUCOSE ROSE TO APPROXIMATELY 800 MG/DL, LEADING TO HOSPITAL ADMISSION; THE AGENT ADVISED THAT AN INFUSION SITE ISSUE COULD HAVE IMPAIRED INSULIN DELIVERY, AND THE USER RECONNECTED THE PUMP AFTER DISCHARGE FROM PDH HOSPITAL. SYMPTOMS INCLUDED HYPERGLYCEMIA WITH COUGHING AND VOMITING. OUTCOMES INCLUDED HOSPITALIZATION AND SUBSEQUENT RECOVERY WITH RESUMPTION OF ILET USE. INVESTIGATION INCLUDED REVIEW OF PUMP CONNECTIVITY AND DATA AVAILABILITY AND USER EDUCATION ON SITE INTEGRITY AND INFUSION TROUBLESHOOTING. INVESTIGATION OF THIS CASE REVEALED THAT THE CAUSE OF HYPERGLYCEMIA REMAINED UNCLEAR, WITH A SUSPECTED POOR INFUSION SITE OR ABSORPTION ISSUE AND NO CONFIRMED DEVICE MALFUNCTION. 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
    166163 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization DEXCOM G7 CGM