BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4886502 · Received July 1, 2015

    Report

    Report Number
    3004193489-2015-00086
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED FOR EVALUATION. TEST STRIP LOT # 1020214287 EXPIRATION DATE: 10/2016. CONTROL SOLUTION LOT # NONE. PER LABEL COPY/PACKAGE INSERT. -UNEXPECTED RESULTS. HIGH OR LOW BLOOD GLUCOSE RESULTS CAN INDICATE POTENTIALLY SERIOUS MEDICAL CONDITIONS. IN CASE OF AN UNEXPECTED RESULT, YOU SHOULD REPEAT THE TEST USING A NEW STRIP. IF THE RESULT IS STILL UNEXPECTED, OR THE READING IS NOT CONSISTENT WITH HOW YOU FEEL, CONTACT YOUR HCP AND TREAT AS PRESCRIBED. ANY CHANGE IN THE TREATMENT OF YOUR DIABETES SHOULD BE -NOVA MAX TEST STRIP INSERT- QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. 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. THE CONSUMER'S COMPLAINT COULD NOT BE CONFIRMED. THE CONSUMER DID NOT RETURN ANY OF THE NOVA MAX BLOOD GLUCOSE TEST STRIPS IN QUESTION. FAILURE ANALYSIS PERFORMED ON THE RETURNED NOVA MAX BLOOD GLUCOSE MONITOR REVEALED NO ANOMALIES. THE METER PERFORMED WITHIN SPECIFICATION. TESTING OF THE RETAIN STRIPS FROM THE SAME LOT NUMBER WAS UNABLE TO DUPLICATE THE ALLEGED DEFICIENCY. THE RETAIN BLOOD GLUCOSE TEST STRIPS WERE FOUND TO PERFORM WITHIN SPECIFICATION AS WELL.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE CONCERNED ABOUT A LOW BLOOD GLUCOSE RESULT. IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE CONSUMER PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 35 MG/DL. BASED ON THIS RESULT THE CONSUMER ORANGE JUICE AS EMERGENT FOOD INTERVENTION TO HELP RAISE HER BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427476 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020214287

    Patients

    Seq Age Sex Outcome Treatment
    1