BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14800620 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00074
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 1, 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
    IN, US
    Reporter Occupation
    003

    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

    PATIENT REPORTED THAT HE APPLIED THE V-GO 20 DEVICE USING PROPER FILL WEAR AND GO PROCEDURE THIS MORNING AND AFTER ABOUT AN HOUR THE V-GO 20 DEVICE STARTED TO BECOME DETACHED FROM PATIENT BODY AND HE FELT A POKING SENSATION. PATIENT REMOVED AND REPLACED HIS V-GO DEVICE SUCCESSFULLY WITH A NEW V-GO DEVICE BUT NOTICED A RED MARK AT THE INJECTION SITE. PATIENT TREATED THE AREA WITH PEROXIDE. PATIENT REPORTS THAT HE SWEATS A LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698018 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 VG221086C 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male