BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 7562646 · Received June 1, 2018

    Report

    Report Number
    1226572-2018-00116
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    January 1, 2018
    Report Date
    May 17, 2018
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE 2 DIABETIC REPORTED THAT HE IS NO LONGER USING V-GO DUE TO HOSPITALIZATION DUE TO HIGH BLOOD SUGARS WHILE ON V-GO. PATIENT COULD NOT PROVIDE ANY ADDITIONAL INFORMATION AT THE TIME OF THE CALL. ALL INFORMATION REGARDING THE HOSPITALIZATION, V-GO THERAPY DETAILS AND INSULIN IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE CANNOT BE DETERMINED BASED ON INFORMATION PROVIDED.

    Description of Event or Problem · 1

    TYPE 2 DIABETIC REPORTED THAT HE IS NO LONGER USING V-GO DUE TO HOSPITALIZATION DUE TO HIGH BLOOD SUGARS WHILE ON V-GO. PATIENT COULD NOT PROVIDE ANY ADDITIONAL INFORMATION AT THE TIME OF THE CALL. ALL INFORMATION REGARDING THE HOSPITALIZATION, V-GO THERAPY DETAILS AND INSULIN IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404144 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization