BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 19981309 · Received August 14, 2024

    Report

    Report Number
    1226572-2024-00044
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT SOMETIME THE START BUTTON ON THE V-GO 20 PATCH POPS OUT DURING THE DAY. SHE HAS BEEN USING THE V-GO DEVICE FOR OVER FEW MONTHS AND HAD THIS PROBLEM A FEW TIMES ALREADY. NO SPECIFIC EVENT DATES WERE REPORTED. IT WAS REPORTED THAT A DEVICE SAMPLE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219751 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female