BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 19760932 · Received July 17, 2024

    Report

    Report Number
    1226572-2024-00036
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE DEVICE FELL OFF EVENT COMPLAINT. THE DEVICE WAS INSPECTED. DUE TO THE CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESIVE PROPERTIES COULD NOT BE VERIFIED, AND THE COMPLAINT FOR THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR V-GO DEVICE POPPED (FELL) OFF HIS ARM WITH THE NEEDLE OUT. THE PATIENT STATED THAT THEY DID NOT BUMP INTO ANYTHING, SO THEY WERE NOT SURE WHY THE DEVICE FELL OFF. THE PATIENT STATED THAT HE MAY HAVE BEEN SWEATY. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365534 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male