BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10923440 · Received November 30, 2020

    Report

    Report Number
    1226572-2020-00460
    Event Type
    Death
    Date Received
    November 30, 2020
    Date of Event
    June 18, 2020
    Report Date
    November 13, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) HAS NOT BEEN ABLE TO SPEAK WITH THE REPORTER FOR THE DATE OF THE DEATH AND THE CAUSE OF DEATH. UPON REVIEW OF THE LIMITED INFORMATION PROVIDED IN THIS REPORT , THERE IS NO REPORTED SUSPICION OF V-GO DEVICE CONTRIBUTION TO THE DEATH. THE SPOUSE APPEARS TO HAVE CALLED FOR ASSISTANCE REGARDING DISPOSING OF UNUSED VGO 30 AND VGO 40 DEVICES. THE DEATH IS CONSIDERED SERIOUS HOWEVER THERE IS NO INFORMATION IN THE REPORT TO INDICATE V-GO CONTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT WIFE CALLED TO REPORT THAT HER HUSBAND HAS PASSED AWAY AND SHE HAS A BOX OF V-GO 30 AND A BOX OF V-GO 40 TO DISPOSE OF AND WAS INQUIRING HOW TO DISPOSE OF THEM. PATIENT'S WIFE STATED THAT PATIENT WAS USING THE V-GO DEVICE WHEN HE PASSED BUT DID NOT WISH TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389168 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death