BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONTIOR

    MDR report key: 5113032 · Received September 30, 2015

    Report

    Report Number
    3004193489-2015-00134
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 19, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020215082, EXPIRATION DATE: 2017/03/31 CONTROL SOLUTION LOT # 1030211209, EXPIRED 2014/01/31. 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 CUSTOMER COMPLAINT IS CONFIRMED. EVALUATION OF THE RETURNED TEST STRIPS READ HIGH OUT OF CONTROL RANGE. THE ROOT CAUSE IS ATTRIBUTED TO THE CONSUMER'S STORAGE AND HANDLING OF THE TEST STRIPS AS EVIDENCED BY THE WEIGHT OF THE RETURNED VIAL FAILING THE WEIGHT TESTING. A FAILURE OF THIS NATURE IS CONSISTENT WITH A COMPROMISED VIAL BY EXPOSURE TO HUMIDITY AND/OR FLUID. THIS FINDING IS FURTHER SUPPORTED BY THE RESULTS OF THE RETAIN STRIP LOT TESTING WHICH CONFIRMS THE RETAIN STRIPS TO PERFORM WITHIN SPECIFICATION. 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 IN CONCERNED ABOUT HIGH BLOOD GLUCOSE READINGS TODAY. IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER CONTINUED TO ADMINISTER UNKNOWN AMOUNTS OF INSULIN BASED ON MULTIPLE HIGH READINGS ON THEIR BLOOD GLUCOSE METER. (B)(6) 2015 ACCORDING TO THE CONSUMER, SHE PERFORMED A BLOOD GLUCOSE TEST AT 8:00 AM GETTING A FASTING RESULT OF 205 MG/DL, BASED ON THIS RESULT SHE ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN; THEN HAD BREAKFAST. THE CONSUMER PERFORMED ANOTHER BLOOD GLUCOSE TEST AT 11:55 AM GETTING A BLOOD GLUCOSE RESULT OF "HI" (GREATER THAN 600 MG/DL) AND REPORTED THAT SHE "... NO FOOD SINCE BREAKFAST..." AT THIS TIME THE CONSUMER ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN BASED ON THIS RESULT. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST THEIR TEST STRIPS FOR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER ONLY HAD EXPIRED CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644265 NOVA MAX LINK GLUCOSE MONTIOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020215082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other