BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3978876 · Received June 27, 2014

    Report

    Report Number
    3004193489-2014-00053
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S BLOOD GLUCOSE METER WAS MISSING THE FIRST DIGIT IN THE LCD SCREEN. THE METER IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377147 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK