BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 12432957 · Received September 7, 2021

    Report

    Report Number
    1226572-2021-00359
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 29, 2021
    Report Date
    August 30, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    0035609400032
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2021 THE NEEDLE BUTTON RELEASED ON ITS OWN. THE PATIENT IS NOT SURE IF HE BUMPED THE DEVICE CAUSING THE NEEDLE TO RELEASE. THE PATIENT NOTICED HE WAS EXPERIENCING HYPERGLYCEMIA AS HIGH AS 168 BECAUSE HIS DEXCOM MONITOR WAS GIVING HIM HIGH GLUCOSE READINGS AT THE TIME WHEN THE NEEDLE RELEASED. THE PATIENT STATED THAT HE HAD BEEN EXPERIENCING SLIGHTLY HIGH GLUCOSE READINGS SINCE HE STARTED ON V-GO BUT COULD NOT PROVIDE SPECIFIC DETAILS AND DATES FOR THE READINGS. THE PATIENT HAS ONLY BEEN ON V-GO THERAPY FOR ABOUT TWO TO THREE WEEKS. THE V-GO 20 DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330304 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG220190B 0035609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other