BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10364222 · Received August 4, 2020

    Report

    Report Number
    1226572-2020-00246
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE EVALUATION RESULTS ARE AS FOLLOWS: THE COMPLAINT ABOUT THE DEVICE FELL OFF COULD NOT BE CONFIRMED. THE ADHESIVE PAD WAS INSPECTED AND FOUND MODERATE ADHESION LEFT ON THE PAD. DUE TO THE USED CONDITION OF THE ADHESIVE PAD, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED.

    Description of Event or Problem · 1

    PATIENT STATED V-GOS FALL OFF AFTER HE SWEATS. PATIENT STATED HE APPLIES V-GOS AT BEDTIME OR IN THE MORNING THE FOLLOWING DAY, BUT AFTER SWEATING FOR AN HOUR AT WORK, THE V-GOS FALL OFF. PATIENT DID NOT PROVIDE SPECIFIC DATES FOR THE EVENTS, STATING THAT THE MOST RECENT EVENT WAS A WEEK AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825196 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR