BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 13400877 · Received January 31, 2022

    Report

    Report Number
    1226572-2022-00007
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 29, 2022
    Report Date
    January 31, 2022
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE #051320-A WAS INSPECTED AND THE REPORTED COMPLAINT ABOUT THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT ON (B)(6) 2022 THE NEEDLE BUTTON ON THE V-GO RELEASED ON IT'S OWN. THE PATIENT APPLIED THE V-GO DEVICE TO HER ABDOMEN. PATIENT STATED THAT THE NEEDLE BUTTON RELEASED ON IT'S OWN WHILE PATIENT WAS SLEEPING AND COULD NOT CONFIRM IF THE V-GO DEVICE HAD BEEN BUMPED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762514 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 VG421024C 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female