BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4972927 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00109
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 13, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED FOR EVAL. THE CONSUMER COMPLAINT IS CONFIRMED. EVAL OF THE RETURNED DEVICE REVEALED THAT THE INTERNAL LCD SCREEN WAS CRACKED AND DAMAGED. THERE WAS NO EVIDENCE OF PHYSICAL DAMAGE TO THE EXTERIOR OF THE BLOOD GLUCOSE MONITOR. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, A CONTRIBUTORY FACTOR MAY BE ATTRIBUTED TO MAINTENANCE OR HANDLING AS THE FAILURE IS CONSISTENT WITH HAVING BEEN DROPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S BLOOD GLUCOSE METER WAS MISSING THE THIRD DIGIT IN THE LCD SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505269 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK