BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14803138 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00084
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 15, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE PATIENT REPORTED THE LOSS OF 11 V- GO 40 DEVICES SINCE (B)(6) 2022 BECAUSE THE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY. PATIENT REPORTS THAT THE AMOUNT OF TIME THE V GO DEVICE STAYS ATTACHED VARIES AND THERE IS NO INTERFERENCE WITH CLOTHING OR INCREASED MOVEMENT AND THE SITE IS ALWAYS PROPERLY PREPARED. PATIENT REPORTS THAT SHE ALWAYS REMOVES AND REPLACES HER V GO DEVICE WITH A NEW ONE WHEN THIS EVENT OCCURS AND REPORTS THAT SHE APPLIED ONE LAST NIGHT AND THIS MORNING IT BECAME DETACHED. PATIENT REPORTS APPLYING A NEW V GO DEVICE AND LOSING THAT SOON AS WELL HAVING TO APPLY A THIRD V GO WITHIN 24 HOUR TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609172 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 VG421152B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female