BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24043344 · Received January 12, 2026

    Report

    Report Number
    3019004087-2026-21156
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 26, 2024
    Report Date
    January 12, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    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 PATIENT EXPERIENCED HYPOGLYCEMIA AFTER MAKING TWO CLOSELY TIMED MEAL ANNOUNCEMENTS AROUND DINNER, WITH THE LOWEST BLOOD GLUCOSE RECORDED AT 51 MG/DL AND DEVICE ALERTS FOR LOW AND URGENT LOW RECEIVED. SYMPTOMS INCLUDED HYPOGLYCEMIA WITHOUT LOSS OF CONSCIOUSNESS OR OTHER ACUTE EFFECTS. OUTCOMES INCLUDED SELF-MANAGEMENT WITH ORAL GLUCOSE AND STABILIZATION WITHOUT MEDICAL INTERVENTION OR ASSISTANCE. INVESTIGATION INCLUDED TROUBLESHOOTING AND EDUCATION ON MEAL ANNOUNCEMENT PRACTICES, INCLUDING GUIDANCE THAT CARBOHYDRATE AMOUNTS UNDER 15 G DO NOT REQUIRE ANNOUNCEMENTS AND THAT AT LEAST 30 MINUTES SHOULD SEPARATE ANNOUNCEMENTS. INVESTIGATION OF THIS CASE REVEALED USER TECHNIQUE CONTRIBUTING TO HYPOGLYCEMIA, AS BACK-TO-BACK ANNOUNCEMENTS LIKELY LED TO EXCESS INSULIN DELIVERY RELATIVE TO INTAKE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER TECHNIQUE RELATED TO MEAL ANNOUNCEMENT TIMING AND QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104209 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown