BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14806172 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00087
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 21, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS CREATED BY (B)(6), DEVICE VIGILANCE SPECIALIST OF ZEALAND PHARMA US, INC. ON BEHALF OF THE MANNKIND, CORP. AS PART OF THE ACQUISITION AND SUBSEQUENT TRANSFER OF THE V-GO MEDICAL DEVICE TO THE LATTER ORGANIZATION. THIS TEMPORARY TRANSITION ACTIVITY IS EXPECTED TO CONTINUE UNTIL SUCH TIME THAT THE ACQUIRING COMPANY ESTABLISHES ITS OWN MDR REPORTING ACCOUNT.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT SHE HAS HAD SOME TROUBLE WITH HER V-GO DEVICES SINCE SHE STARTED USING V-GO ABOUT TWO YEARS AGO. THE PATIENT STATED THAT SOME OF THE V-GO DEVICES HAVE FALLEN OFF, WITH THE MOST RECENT ONES ABOUT TWO WEEKS AGO. THE PATIENT CONFIRMED THAT SHE PREPARES THE APPLICATION SITE WITH AN ALCOHOL PREP PRIOR TO APPLYING THE V-GO DEVICE AND THAT SHE APPLIES IT WHILE IN A SITTING POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931904 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 VG321049C 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female