BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23711301 · Received December 3, 2025

    Report

    Report Number
    3019004087-2025-10846
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    May 26, 2024
    Report Date
    December 3, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    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 THE USER EXPERIENCED HYPERGLYCEMIA AFTER BEING DISCONNECTED FROM THE ILET SYSTEM FOR TWO DAYS DUE TO A CHARGER ISSUE AND THEN RECONNECTING AT MIDNIGHT, WITH BLOOD GLUCOSE READINGS REMAINING ELEVATED AROUND 180¿207 MG/DL DESPITE NO REPORTED FURTHER RISE, SUGGESTING THE INFUSION SET WAS DELIVERING INSULIN BUT CONTROL WAS SUBOPTIMAL FOLLOWING THE INTERRUPTION. SYMPTOMS INCLUDED NO ACUTE CLINICAL EFFECTS. OUTCOMES INCLUDED NO MEDICAL INTERVENTION, NO HOSPITALIZATION, NO KETONE TESTING, AND NO USE OF BACKUP THERAPY. TROUBLESHOOTING AND EDUCATION WERE PROVIDED, INCLUDING GUIDANCE TO MONITOR GLUCOSE CLOSELY AND CONSIDER A SUPPLY CHANGE IF GLUCOSE ROSE. INVESTIGATION INCLUDED REVIEW OF USER REPORT AND TROUBLESHOOTING GUIDANCE. INVESTIGATION OF THIS CASE REVEALED AN UNCLEAR CAUSE OF HYPERGLYCEMIA FOLLOWING A PROLONGED DISCONNECTION AND SUBSEQUENT RECONNECTION. IT WAS CONCLUDED THAT THE EVENT WAS USER-REPORTED HYPERGLYCEMIA WITH CAUSE UNCLEAR AND NO CONFIRMED DEVICE MALFUNCTION. THE DEVICE HAS NOT BEEN RETURNED. IF IT IS RETURNED, IT WILL BE EVALUATED, AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2862996 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Other