BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS SYSTEM

    MDR report key: 20171336 · Received September 6, 2024

    Report

    Report Number
    MW5159331
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 29, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BETA BIONICS ILET PUMP CARTRIDGE HAD NOTABLE LEAK OF INSULIN, WHICH RESULTED IN NO DELIVERY OF BOLUS OR BASAL INSULIN. THE 12 Y.O. BOY DEVELOPED DKA (GLUCOSE 673 MG/DL, PH <7.3, KETONES (BOH) OF 5.64) REQUIRING IV INSULIN DRIP AND IV FLUIDS. HE HAD UNEVENTFUL HOSPITAL COURSE AND WAS TRANSITIONED TO SQ INSULIN REGIMENT WITH MULTIPLE DAILY INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329905 ILET BIONIC PANCREAS SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Hospitalization| R