BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10172075 · Received June 18, 2020

    Report

    Report Number
    1226572-2020-00210
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 16, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400032
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT LAST WEEK 2 V-GOS LOOSENED AFTER NEARLY 12 HOURS OF WEAR. PATIENT DID NOT RECALL THE DATE OF THE 1ST EVENT. PATIENT STATED 2ND EVENT WAS (B)(6) 2020. PATIENT STATED SHE WORE THE V-GOS ON HER ABDOMEN, SLEPT ROUGHLY AND THAT THE EXTRA MOVEMENT MIGHT HAVE CONTRIBUTED TO THE LOOSENING OF THE V-GOS. PATIENT STATED SHE DISCARDED ALL V-GOS WORN PRIOR TO TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634029 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG220012B 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR