BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 16372962 · Received February 14, 2023

    Report

    Report Number
    1226572-2023-00007
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 26, 2023
    Report Date
    January 26, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A V-GO REPRESENTATIVE STATED A PATIENT REPORTED TO THEM THAT THE BUTTON OF THE PATIENT'S V-GO IS POPPING BACK UP. THE PATIENT WAS CONTACTED AND CONFIRMED THAT THE V-GO WAS ATTACHED TO THEIR BODY AT 6AM AND IT POPPED BACK UP (RELEASED) AT 8AM. IT WAS REPORTED THAT RETRAINING WAS PROVIDED TO THE PATIENT BY THE V-GO REPRESENTATIVE. THE PATIENT STATED THAT NO DEVICE IS AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810043 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male