BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8709026 · Received June 18, 2019

    Report

    Report Number
    1226572-2019-00070
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 3, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT THAT V-GOS FALL OFF AFTER HER SWEATS. PATIENT DID NOT RECALL SPECIFIC DATES OR QUANTITY OF DEVICES THAT FELL OFF LAST WEEK. PATIENT STATED THAT THE V-GOS WORN WHILE WORKING IN CEILINGS AND OUTDOORS FELL OFF AFTER NEARLY 4 HOURS OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503282 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR