BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10391126 · Received August 11, 2020

    Report

    Report Number
    1226572-2020-00285
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S TERRITORY BUSINESS LEADER (TBL) CALLED IN TO REPORT THAT THE SOME V-GOS FELL OFF. THE TBL WAS NOT ABLE TO PROVIDE V-GO OPTION, TYPE OF INSULIN, LOT NUMBERS AND EXPIRATION DATES, HOW MANY HOURS THE V-GOS WERE WORN, OR WHAT CAUSED THEM TO FALL OFF. SHE REPORTED THEY WERE WORN ON THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857300 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR