BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 19806496 · Received July 23, 2024

    Report

    Report Number
    1226572-2024-00040
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT IN THE LAST SIX MONTHS, THEY HAVE BEEN EXPERIENCING THE V-GO DEVICES FALLING OFF. NO SPECIFIC EVENT DATES OR NUMBER OF OCCURRENCES 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
    935960 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male