BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 18093427 · Received November 8, 2023

    Report

    Report Number
    1226572-2023-00126
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 19, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400018
    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 NEEDLE BUTTON RELEASED COMPLAINT. DEVICE #053173-A WAS INSPECTED, AND THE NEEDLE MECHANISM FUNCTIONS WERE TESTED AND VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THE NEEDLE BUTTON OF THEIR V-GO 40 RELEASED. THE PATIENT REPORTED THAT THEY WERE JUST STANDING, AND THEY HEARD IT CLICK/POP OUT. IT WAS REPORTED THAT THE DEVICE 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
    1537295 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 VG422062B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female