BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 11392024 · Received March 1, 2021

    Report

    Report Number
    1226572-2021-00080
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    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 · 1

    THE PATIENT REPORTED OVER TIME, PATIENT HAS HAD ABOUT FOUR OR FIVE V-GOS ON WHICH THE NEEDLE RETRACTED OUT OF HIS BODY BEFORE THE 24 HOURS . PATIENT MAY HAVE BUMPED IT ON OCCASION, BUT THERE WERE OTHER TIMES PATIENT IS SURE HE DID NOT. PATIENT STATED THE LAST ONE HAPPENED ABOUT A MONTH AGO. ON SOME OCCASION'S PATIENT WAS ABLE TO PUSH THE NEEDLE BUTTON BACK IN AND IT STAYED IN. PATIENT WEARS THE V-GO ON HIS ABDOMEN. THE PATIENT DID NOT SAVE ANY OF THESE V-GOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288850 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR