BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8710111 · Received June 18, 2019

    Report

    Report Number
    1226572-2019-00079
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 6, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    UDI-DI
    00385609400025
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED ON (B)(6) 2019 AND INVESTIGATED. THE INVESTIGATION RESULTS ARE AS FOLLOWS: THE COMPLAINT WAS CONFIRMED. THE LOCKING SPRING WAS FOUND TO HAVE BEEN ASSEMBLED INCORRECTLY, ONCE THE FINDING WAS CORRECTED, THE DEVICE NEEDLE BUTTON FUNCTIONED WITH NO FURTHER ISSUE. THE ROOT CAUSE WAS CONFIRMED TO BE AN ASSEMBLY ERROR WITH THE LOCKING SPRING. SCAR 275 HAS BEEN OPENED.

    Description of Event or Problem · 1

    THE PATIENT CALLED IN TO REPORT THAT WHEN SHE DEPRESSED THE NEEDLE BUTTON ON TWO OF HER V-GOS THE NEEDLE BUTTON WENT IN BUT AFTER A FEW MINUTES THE NEEDLE BUTTON RELEASED. SHE TOOK OFF THE V-GOS AND PUT ON A NEW V-GO EACH TIME. SHE VERIFIED SHE DID NOT ACCIDENTALLY HIT THE NEEDLE RELEASE BUTTON, OR BUMP UP AGAINST SOMETHING. SHE WORE BOTH V-GOS ON THE ABDOMEN. I WENT OVER PROPER PLACEMENT AND THE PATIENT IS FOLLOWING PROPER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500563 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 VG318196B 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1