BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24832586 · Received April 9, 2026

    Report

    Report Number
    MW5186561
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    April 5, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BETA BIONIC / BETA BIONICS, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD MY THIRD DIABETIC LOW CAUSING ME TO GO TO THE EMERGENCY ROOM IN THE LAST 5 MONTHS. ON THIS DATE, I WENT DOWN TO 22, FELL OFF MY BED AND INJURED MY FACE IN THREE LOCATIONS, AND EXHIBITED SEIZURE-LIKE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408433 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONIC / BETA BIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| L BIRTH CONTROL.| BUSPIRONE.| CRANBERRY PILL.| GUMMY MULTIVITAMIN.| INSULIN.| TURMERIC.| ZYRTEC.