BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14238123 · Received April 28, 2022

    Report

    Report Number
    1226572-2022-00047
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 19, 2022
    Report Date
    April 19, 2022
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) PHARMA AE ASSESSOR SPOKE TO THE FAMILY MEMBER OF THE VGO USER FOR FURTHER INVESTIGATION OF THE COMPLAINT. NO ADDITIONAL INFORMATION ABOUT THIS COMPLAINT COULD BE OBTAINED. THE INFORMATION PROVIDED BY CC IS THE INFORMATION THAT IS AVAILABLE. THE VGO CANNOT BE EXCLUDED FROM THE SERIOUS COMPLAINT. HOWEVER, THE PATIENT WAS JUST RESTARTED ON THE VGO AND THE CAREGIVER DID NOT KNOW HOW MANY CLICKS TO GIVE. THEREFORE, THE VGO IS UNLIKELY CONTRIBUTING TO THE HYPERGLYCEMIA BUT RATHER THE UNCONTROLLED BG LEVEL AND MANAGEMENT PRIOR TO RESTARTING THE VGO WERE THE LIKELY CONTRIBUTING FACTORS AND THEN NOT KNOWING HOW MANY CLICKS TO GIVE ALSO CONTRIBUTED TO THE HYPERGLYCEMIA.

    Description of Event or Problem · 0

    THE PATIENTS DAUGHTER AND PHYSICIAN OFFICE ASSISTANT (POA) CALLED REGARDING THE PATIENTS BOLUS CLICKS. PATIENT'S DAUGHTER WAS NOT SURE HOW MANY CLICKS SHE WAS SUPPOSED TO GIVE THE PATIENT. POA STATED THE PATIENT HAS BEEN ON AND OFF V-GO OFTEN AND WAS JUST PUT BACK ON IT. PATIENT'S DAUGHTER WAS ADVISED THE PATIENTS HCP WILL ADVISE THEM ON HOW MANY CLICKS THE PATIENT REQUIRES. PATIENT'S DAUGHTER INFORMED ME THE PATIENTS BLOOD SUGAR WAS AT 507 AND PATIENT WAS BREATHING HEAVY. PATIENT DAUGHTER STATED SHE WAS UNSURE IF THE PATIENT HAD ANY SYMPTOMS FROM THE HIGH BLOOD SUGAR BECAUSE THE PATIENT DOES NOT SPEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118864 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Life Threatening