BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DEVICE

    MDR report key: 14501218 · Received May 25, 2022

    Report

    Report Number
    1226572-2022-00058
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 13, 2022
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    000385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE NEEDLE BUTTON RELEASED EVENT. DEVICE #051871-A WAS INSPECTED, AND THE NEEDLE MECHANISM FUNCTIONS WERE TESTED AND WERE VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT OVER THE PAST FEW MONTHS, THEY HAVE HAD 5 TO 6 V-GO 40 DEVICES THAT THE NEEDLE BUTTON RELEASED ON ITS OWN. THE MOST RECENT OCCURRENCE HAPPENED ON 05/13/2022 IN WHICH THE NEEDLE BUTTON RELEASED ON ITS OWN ABOUT AN HOUR AND A HALF AFTER INSERTION. THE PATIENT STATED WITH SOME DEVICES THEY HAVE BEEN ABLE TO PUSH THE NEEDLE BUTTON BACK IN. THE PATIENT CONFIRMED THEY PRESSED THE ROUND PORTION OF THE NEEDLE BUTTON AND SOMETIMES THEY WILL PRESS THE ENTIRE NEEDLE BUTTON. THE PATIENT STATED ONE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293238 V-GO DISPOSABLE INSULIN DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 FG421138 000385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male