BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 15242254 · Received August 17, 2022

    Report

    Report Number
    1226572-2022-00113
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 19, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400032
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 #052227-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 CONTACTED V-GO CUSTOMER CARE (VCC) AND REPORTED THAT THE NEEDLE BUTTON DID NOT LOCK DOWN AND ALSO THAT WHILE USING V-GO THE NEEDLE POPPED OUT. THE PATIENT WAS OUT, AND HE TRIED TO GET THE NEEDLE BACK IN BUT AFTER A WHILE THE NEEDLE CAME OUT AGAIN. VCC ADVISED THE PATIENT TO ALWAYS REPLACE V-GO IF THAT SITUATION HAPPENS AGAIN. HE CONFIRMED THAT HE WEARS V-GO ON HIS ABDOMEN AND CHANGES SITES. HE SAID THAT THIS IS THE SECOND TIME THIS HAPPENED. HE CONFIRMED THAT HE DID NOT PUSH THE NEEDLE RELEASE BUTTON BY ERROR. THE PATIENT MENTIONED THAT HE IS WAS NOT AWARE ABOUT THAT THE COVER PIN NEEDS TO BE ATTACHED TO THE BUTTON COVER, SO HE WAS NOT SURE IF IT WAS. WHEN ASKED IF HE PUSHED THE BUTTON COVER OVER THE ROUNDED SIDE, HE SAID HE JUST PUSH IT AND THEN STARTED WEARING V-GO. HE MENTIONED THAT THIS IF THE FIRST TIME SOMEONE MENTIONS THESE TO HIM AND THAT HE WILL BE MORE AWARE ABOUT THAT. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238233 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 VG221116B 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male