BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 19721930 · Received July 11, 2024

    Report

    Report Number
    1226572-2024-00038
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400032
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: SIX DEVICES WERE RECEIVED AND EVALUATED FOR THE DEVICE FELL OFF EVENT COMPLAINT. DEVICE #053516-A TO -D WERE INSPECTED. THESE DEVICES WERE RETURNED UNUSED AND ASSESSED, AND IT WAS VERIFIED THAT ENOUGH ADHESIVE WAS OBSERVED ON THE FOAM PAD. NO ANOMALY WAS OBSERVED WITH THE PROTECTIVE LINER. THE COMPLAINT THESE DEVICES COULD NOT BE CONFIRMED. DEVICE #053516-E TO -F WAS RECEIVED AND INSPECTED. DUE TO THE CONDITION OF THE ADHESIVE FOAM PAD UPON RECEIPT, THE ORIGINAL ADHESION PROPERTIES COULD NOT BE VERIFIED, AND THE COMPLAINT ABOUT THESE DEVICES COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT CALLED TO REPORT THAT V-GO 20 DEVICES FOR THE PAST 7 DAYS HAD ADHESIVE ISSUE AND FAILED TO STAY ON CLEAN SKIN. IT WAS REPORTED THAT DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385068 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 20 FG223107 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female