BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 15537688 · Received October 4, 2022

    Report

    Report Number
    1226572-2022-00149
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 11, 2022
    Report Date
    September 13, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE DEVICE FELL OFF EVENT. DEVICE #052461-A WAS INSPECTED AND NO ISSUE WAS OBSERVED. DUE TO THE USED CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED. THE COMPLAINT FOR THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    A PATIENT'S SPOUSE CALLED AND REPORTED FOUR INSTANCES WHEN THE V-GO DEVICE FELL OFF OF THE PATIENT'S ARM DURING USE. THE SPOUSE SAID THEY HAVE TRIED TO APPLY THE V-GO TO OTHER AREAS OF THE BODY WITHOUT SUCCESS. A DEVICE WAS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER TO DATE IT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507372 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 VG421122B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male