BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DEVICE

    MDR report key: 15028300 · Received July 15, 2022

    Report

    Report Number
    1226572-2022-00101
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 26, 2022
    Report Date
    June 27, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE NEEDLE BUTTON RELEASED EVENT. DEVICE # 052106-A WAS RECEIVED WITH THE NEEDLE RELEASED BUTTON ACTIVATED IN THE DEPRESSED POSITION (STEP 2 OF 2). THE FUNCTIONAL TEST INDICATES THAT THE DEVICE WHEN IT WAS RESET, OPERATED AS INTENDED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE PATIENT CONTACTED THE V-GO CALL CENTER (VCC) AND REPORTED THAT THE NEEDLE BUTTON POPPED OUT AFTER 2-3 HOURS. THE PATIENT WEARS V-GO ON THEIR ABDOMEN. VCC ADVISED THE PATIENT THAT WHEN THIS HAPPENS THAT V-GO DEVICE NEEDS TO BE DISCARDED AND REPLACED WITH A NEW ONE. THE PATIENT SHARED THAT THEY REMOVED THE V-GO DEVICE AND WAITED UNTIL THE 24-HOUR PERIOD WAS DUE AND PUT A NEW V-GO. THE PATIENT STATED THAT THIS IS THE FIRST TIME THIS HAPPENED. VCC REVIEWED WITH THE PATIENT THE PROCESS OF CHOOSING AN INFUSION SITE AND WHAT TO AVOID. THE PATIENT WAS ADVISED TO PUSH THE NEEDLE BUTTON ON THE ROUNDED SIDE OR RAISED BUMP. THE PATIENT CONFIRMED THAT THEY DID NOT CLICK THE NEEDLE RELEASE BUTTON BY ERROR. 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
    1047667 V-GO DISPOSABLE INSULIN DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 FG321150 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male