BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 12303066 · Received August 10, 2021

    Report

    Report Number
    1226572-2021-00333
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 17, 2021
    Report Date
    August 5, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K4103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WILL BE OUT OF V-GO DEVICES BEFORE HE CAN FILL HIS NEXT PRESCRIPTION, THE PATIENT MENTIONED THAT EVERY OTHER V-GO DEVICE HAS FALLEN OFF OF THE BACK OF HIS ARM WITH THE LAST BOX OF V-GO DEVICES THAT HE STARTED USING IN MID-JULY. THE PATIENT ESTIMATES THAT IT MAY HAVE BEEN ABOUT 10 V-GO DEVICES THAT HAVE FALLEN OFF IN ABOUT AN HOUR INTO USE AND HE CONFIRMED THAT HE USES AN ALCOHOL SWAB TO CLEAN THE INFUSION SITE PRIOR TO APPLYING THE V-GO. THE PATIENT DISPOSED OF THE WORN V-GO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196076 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 46 YR