BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 17564768 · Received August 17, 2023

    Report

    Report Number
    1226572-2023-00090
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 31, 2023
    Report Date
    July 31, 2023
    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 NEEDLE BUTTON RELEASED EVENT COMPLAINT. DEVICE #053031-A WAS RECEIVED, 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 STATED SHE HAD A V-GO 20 ON, AND THE NEEDLE PULLED OUT FROM HER SKIN AND SHE COULD NOT GET IT TO GO BACK IN. IN THE PAST WHEN THAT HAPPENED, SHE WOULD PUSH IT BACK IN AND SCOTCH TAPE IT ON. THE SPECIFIC EVENT DATES OR NUMBER OF OCCURRENCES WERE NOT PROVIDED. THE DEVICES WERE REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994077 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female