BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8944190 · Received August 29, 2019

    Report

    Report Number
    1226572-2019-00334
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 13, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A LOW READING OF 33 ON (B)(6) 2019 AT 4AM. PATIENTS HUSBAND ATTEMPTED TO WAKE THE PATIENT UP AND WHEN PATIENT DID NOT HE CALLED THE PARAMEDICS. PARAMEDICS ADMINISTERED GLUCOSE GEL, OJ AND PEANUT BUTTER AT HOME AND THE PATIENT RECOVERED WITH THE ORAL CARBOHYDRATE PATIENT DID NOT GO TO THE HOSPITAL FOR THE HYPOGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737805 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention