BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 12075086 · Received June 28, 2021

    Report

    Report Number
    1226572-2021-00261
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 21, 2021
    Report Date
    June 25, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CASE MANAGER AND DIABETES EDUCATOR FROM (B)(6) REPORTED THAT THE PATIENT HAS BEEN AT THE HOSPITAL DUE TO HYPERGLYCEMIA SINCE (B)(6) 2021. THE CASE MANAGER REPORTED THE FOLLOWING VALUES: - 534 (B)(6) 8:14 PM , 400 (B)(6) 2021 2:55 AM- 278 LAST NIGHT, (B)(6) 2021 BEFORE BED AND 171, 3 HOURS BEFORE. THE CASE MANAGER INDICATED THAT NORMAL SUGAR READINGS FOR THIS PATIENT IS BETWEEN 101-171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971173 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L