BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 12525960 · Received September 24, 2021

    Report

    Report Number
    1226572-2021-00369
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400025
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE EVALUATION RESULT IS AS FOLLOWS: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE NEEDLE BUTTON RELEASED EVENT. THE DEVICE #050395-4 WAS INSPECTED, AND THE NEEDLE MECHANISM FUNCTIONS WERE TESTED AND WERE VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT AUTHORIZED CONTACT TO REPORT THAT THE NEEDLE BUTTON IS NOT WORKING ON MULTIPLE OF THE PATIENT DEVICES. AUTHORIZED CONTACT STATED THIS OCCURRED WITH 7 OF THE DEVICES. ON EACH OF DEVICES AUTHORIZED CONTACT STATED THE NEEDLE BUTTON POPPED AFTER SO MANY HOURS THE NEEDLE BUTTON JUST POPPED BACK UP ON ITS OWN. AUTHORIZED CONTACT STATED THE NEEDLE RELEASE BUTTON WAS NOT ACCIDENTALLY ACTIVATED ON ANY OF THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426122 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 VG320081B 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR