BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8776391 · Received July 10, 2019

    Report

    Report Number
    1226572-2019-00128
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CALLED IN TO REPORT THAT ON TWO OF HER V-GOS THE NEEDLE BUTTON RELEASED PRIOR TO THE END OF THE 24 HOUR PERIOD. PATIENT SAID SHE COULD NOT SAY HOW LONG THE V-GOS WERE ON BEFORE THE RELEASE. VCC REPRESENTATIVE WENT OVER PROPER PLACEMENT AND ALSO VERIFIED SHE HAD NOT BUMPED INTO ANYTHING OR ACCIDENTALLY HIT THE NEEDLE RELEASE BUTTON. VCC REPRESENTATIVE ALSO VERIFIED THAT PATIENT THREW THEM AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568973 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-G0 LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR