BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 11358100 · Received February 22, 2021

    Report

    Report Number
    1226572-2021-00062
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 3, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400032
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE RETURNED AND EVALUATED. THE EVALUATION RESULTS ARE AS FOLLOWS: TWO DEVICES WERE RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE NEEDLE BUTTON RELEASED EVENT. THE TWO DEVICES WERE RETURNED WITH THE NEEDLE RELEASE BUTTON DEPRESSED (STEP 2 OF 2) WHICH IS IN THE ACTIVATED LOCKOUT POSITION. THE NEEDLE MECHANISM WAS TESTED AND WAS VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THESE DEVICES.

    Description of Event or Problem · 1

    PATIENT RETURNED TWO DEVICES WITH A HAND WRITTEN NOTE STATING ON THE DATES OF (B)(6) 2021 THE V-GO WS APPLIED AT 8PM AND THE NEEDLE CAME OUT AT 10:30 PM. THE SECOND DEVICE WORN ON (B)(6) 2021 APPLIED AT 8PM AND THE NEEDLE CAME OUT AT 4:45 AM .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260218 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG220099B 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR