BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8819405 · Received July 23, 2019

    Report

    Report Number
    1226572-2019-00185
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 3, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE V-GO IS NOT ADHERING AS IT SHOULD. PATIENT MENTIONED AS SHE IS SLEEPING SOMETIMES THE V-GO FALLS OFF. PATIENT IS PLACING THE V-GO ON HER LOWER ABDOMEN, ABDOMEN AND BACK ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612463 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR