BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 5111179 · Received September 29, 2015

    Report

    Report Number
    3004193489-2015-00136
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020214365 EXPIRATION DATE: 2016/12/31. CONTROL SOLUTION LOT # 1030514339 RANGE 82-127 MG/DL. PER LABEL COPY/ PACKAGE INSERT: 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 TEST 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 DISCUSSED WITH YOUR HCP. 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.

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S ALLEGED DEFICIENCY COULD NOT BE CONFIRMED. ALTHOUGH THE REPORTED RESULTS WERE FOUND IN THE MEMORY OF THE RETURNED DEVICE, FAILURE ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THE NOVA MAX LINK GLUCOSE MONITORING DEVICE PERFORMED WITHIN SPECIFICATION. THE CUSTOMER RETURNED BLOOD GLUCOSE TEST STRIP FROM THE LOT IN QUESTION. VISUAL AS WELL AS CHEMICAL EVALUATION (BY TESTING WITH CONTROL SOLUTION) WAS NOT ABLE TO REPLICATE THE ALLEGED ISSUE AS THE PERFORMANCE TESTING REVEALED THE STRIPS TO PERFORM WITHIN SPECIFICATION AS WELL. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT A HIGH BLOOD GLUCOSE RESULT SHE GOT THIS MORNING. ACCORDING TO THE CONSUMER SHE PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 163 MG/DL AND BASED ON THAT RESULT SHE ADMINISTERED THREE (3) UNITS OF INSULIN. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642021 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020214365

    Patients

    Seq Age Sex Outcome Treatment
    1