BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24793319 · Received April 6, 2026

    Report

    Report Number
    3019004087-2026-41454
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    July 8, 2025
    Report Date
    April 6, 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

    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 THE USER EXPERIENCED LOW BLOOD GLUCOSE WHILE USING A CONTINUOUS GLUCOSE MONITORING SYSTEM IN CONJUNCTION WITH THE ILET, WITH FINGERSTICK READINGS OF 68 AND 66 MG/DL AND CONCERNS ABOUT SENSOR CONNECTIVITY DUE TO LACK OF INTERNET OR WI-FI. SYMPTOMS INCLUDED HYPOGLYCEMIA. OUTCOMES INCLUDED SELF-TREATMENT WITH ORAL GLUCOSE. INVESTIGATION INCLUDED TROUBLESHOOTING AND EDUCATION PROVIDED BY SUPPORT, INCLUDING GUIDANCE TO RECONNECT WHEN INTERNET OR WI-FI IS AVAILABLE TO IMPROVE DATA TRANSMISSION AND SENSOR FUNCTIONALITY. INVESTIGATION OF THIS CASE REVEALED THAT THE CAUSE OF THE HYPOGLYCEMIA WAS UNCLEAR, AND NO DEVICE MALFUNCTION WAS IDENTIFIED BASED ON AVAILABLE INFORMATION. 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
    600560 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other