BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14800858 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00077
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 6, 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
    TX, 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION C, COMBINATION PRODUCT INADVERTENTLY OMITTED ON INITIAL SUBMISSION. FIELD HAS BEEN CORRECTED TO "NO". DEVICE EVALUATION: TWO DEVICES WERE RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE DEVICE FELL OFF EVENT. BOTH DEVICES WERE INSPECTED, AND DUE TO THE USED CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED. THE COMPLAINT ABOUT THESE DEVICES COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT'S DAUGHTER REPORTED THAT MOTHER HAD ABOUT FIVE V-GO 20 DEVICES FALL OFF ABOUT AN HOUR AFTER APPLICATION. THE DAUGHTER CONFIRMED THAT THE PATIENT IS PREPARING THE APPLICATION SITE WITH AN ALCOHOL PREP PRIOR TO APPLYING THE V-GO 20 DEVICE. THE PATIENT IS CURRENTLY USING ADHESIVE TAPE TO KEEP THE V-GO DEVICE CURRENTLY WEARING FROM FALLING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072634 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 FG221133 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female