BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 18668456 · Received February 8, 2024

    Report

    Report Number
    1226572-2024-00006
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 19, 2024
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE DEVICE FELL OFF EVENT. DEVICE #053316-A WAS INSPECTED. DUE TO THE CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED. FUNCTION TESTS WERE PERFORMED AND VERIFIED THAT THE ADHESION STRENGTH WAS SUFFICIENT. THE COMPLAINT ABOUT THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEY APPLIED THEIR V-GO AND IT FELL OFF WHEN THEY TOOK A SHOWER. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787829 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 FG223061

    Patients

    Seq Age Sex Outcome Treatment
    1