BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 15184593 · Received August 8, 2022

    Report

    Report Number
    1226572-2022-00109
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 17, 2022
    Report Date
    July 18, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400025
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THREE DEVICES WERE RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE NEEDLE BUTTON RELEASED EVENT. DEVICE #052218-A AND #052218-B WERE RECEIVED, AND THE NEEDLE MECHANISM FUNCTIONS WERE TESTED AND VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THESE DEVICES. DEVICE #052218-C WAS RECEIVED WITH NO COMPRESSION SPRING; DUE TO THE MISSING COMPONENT, THE REPORTED COMPLAINT COULD NOT BE EVALUATED. THE COMPLAINT ABOUT THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT ON (B)(6) 2022, HE HAD A V-GO WHERE THE NEEDLE BUTTON POPPED OUT PRIOR TO THE COMPLETION OF THE 24-HOUR PERIOD. THE PATIENT CONFIRMED THAT HE PRESSES ON THE RAISED CIRCULAR BUMP OF THE NEEDLE BUTTON. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371202 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 VG321068C 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male