BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2803125 · Received October 19, 2012

    Report

    Report Number
    3004193489-2012-00067
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    August 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REVEALED UPON THE INVESTIGATION OF THE CONSUMER'S RETURNED BLOOD GLUCOSE METER THAT THE FIRST DIGIT IS MISSING IN THE LCD SCREEN. MEETING THE REQUIREMENTS OF AN MEDICAL DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020211136

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK