BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 4203710 · Received October 23, 2014

    Report

    Report Number
    1226572-2014-00012
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOLLOWING OUR PROCEDURE: PT WAS HOSPITALIZED FOR HYPERGLYCEMIA AND DKS WHICH CONSTITUTES A SERIOUS ADVERSE EVENT. DEVICE UNAVAILABLE FOR INVESTIGATION. INSUFFICIENT INFO AVAILABLE TO EXPLAIN IF V-GO CONTRIBUTED TO THE EVENT OR NOT.

    Description of Event or Problem · 1

    TYPE ONE DIABETES ON SECOND DAY OF V-GO THERAPY, REPORTED TO VALERITAS CUSTOMER CARE (VCC) THAT "SHE HAS BEEN EXPERIENCING EXCESSIVE VOMITING." AE ASSESSOR SPOKE WITH PT FOR FURTHER INVESTIGATION OF THIS CASE. PT REPORTS THAT AFTER THIS REPORT TO VCC, SHE WAS HOSPITALIZED WITHIN THE NEXT DAY OR TWO FOR DKA (PT DISCHARGE). PRE-VGO PT BG WAS IN THE 300 TO 400 RANGE AND SHE WAS ON LANTUS 30 UNITS DAILY WITH NOVOLOG 15 UNITS PER MEAL. PT REPORTS THAT HER BG ON THE VGO 20 WAS 250 TO HIGH 400 RANGE. PT REPORTS THAT HER BG ON THE VGO 20 WAS 250 TO HIGH 400 RANGE. PT REPORTS TO AE ASSESSOR THAT SHE CHANGED HER V-GO EVERY 24 HOURS AND THE NEEDLE WAS ACTIVATED AND ENGAGED IN HER BODY. PT STATES TO THE AE ASSESSOR THAT THE V-GO 20 "WAS NOT ENOUGH INSULIN" FOR HER NEEDS AND SHE HAS RETURNED TO INJECTION THERAPY. DEVICE PT WAS WEARING IS UNAVAILABLE. LOT NUMBER AND EXPIRATION DATE IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676668 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 20 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization