BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10620390 · Received October 2, 2020

    Report

    Report Number
    1226572-2020-00383
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    October 1, 2019
    Report Date
    October 1, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE PREVIOUSLY WAS TAKING V-GO 30 IN (B)(6) 2019 BUT HAD 2 INCIDENTS OF HYPOGLYCEMIA AND WAS TAKEN OFF OF V-GO IN (B)(6) 2019. THE PATIENT REPORTED THAT WITH THE FIRST INCIDENT, HER BG WENT DOWN TO 40 AND SHE WAS TAKEN TO THE EMERGENCY ROOM AT TEXAS HEALTH HEB. THE PATIENT DID NOT PROVIDE HER BG READING WITH REGARD TO THE SECOND INCIDENT BUT RECOGNIZED THE LOW ON HER OWN AND ATE TO BRING HER BLOOD SUGAR BACK UP. THE PATIENT COULD NOT PROVIDE SPECIFIC DATES WITH REGARD TO THE HYPOGLYCEMIC EVENTS. THE PATIENT DISPOSED OF THE WORN V-GO'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083999 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization