BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 17817374 · Received September 26, 2023

    Report

    Report Number
    1226572-2023-00108
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    July 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT A FEW YEARS BACK WHEN HE FIRST STARTED V-GO, HE RECEIVED A STARTER KIT OF V-GO. SINCE THEN, HE HAS BEEN USING THE STARTER KIT V-GO AS BACK UP IN CASE HIS NORMAL SCRIPT OF V-GO FALLS OFF. HE STATED THAT OVER THE YEARS HE HAS EXPERIENCED ABOUT 12 THAT HAVE FALLEN OFF AND HE HAD TO USE HIS STARTER KIT ONES TO REPLACE. PER THE PATIENT, THE MOST RECENT TIME THE DEVICE FELL OFF WAS ABOUT 2 MONTHS AGO. THE REMAINING EVENT DATES WERE NOT PROVIDED. NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831118 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male