BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 16915130 · Received May 11, 2023

    Report

    Report Number
    1226572-2023-00037
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    February 1, 2023
    Report Date
    April 24, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE DEVICE FELL OFF EVENT COMPLAINT. DEVICE #052812-B WAS INSPECTED, BUT DUE TO THE USED CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED. THE COMPLAINT FOR THE DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR V-GO 20 FELL OFF SOMETIME IN (B)(6) 2023 (EXACT DATE UNKNOWN). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053325 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female