BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4886505 · Received July 1, 2015

    Report

    Report Number
    3004193489-2015-00079
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 7, 2015
    Report Date
    June 8, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WERE 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 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 -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 CUSTOMER'S COMPLAINT IS CONFIRMED. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE NOVA MAX LINK GLUCOSE MONITORING DEVICE PERFORMED WITHIN SPECIFICATION. VISUAL AS WELL AS CHEMICAL EVALUATION (BY TESTING WITH CONTROL SOLUTION) OF THE RETURNED GLUCOSE TEST STRIPS REVEALED ONE OF THE STRIPS TO BE COMPROMISED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED. A POTENTIAL CONTRIBUTORY ROOT CAUSE MAY BE RELATED TO EXPOSURE OF THE TEST STRIPS TO EXTREMES IN TEMPERATURE CONTRARY TO THE STORAGE AND HANDLING AS INDICATED IN LABEL COPY (IFU/PACKAGE INSERT) THIS IS FURTHER SUPPPORTED BY THE RESULTS OF THE RETAIN STRIP TESTING WHICH INDICATES THE PERFORMANCE OF THE RETAIN STRIPS ARE WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE TO REPORT, "WHEN SHE OPENED HER NEW BOX OF TEST STRIPS, SHE FOUND THE CAP OF THE VIAL INSIDE WAS OPENED." THE CONSUMER ADMITTED THAT SHE PERFORMED BLOOD GLUCOSE TESTS GETTING THE FOLLOWING RESULTS USING LOT # 1020214287 VIAL WITH OPEN CAP. CONSUMER ADMINISTERED 5 UNITS INSULIN. ACCORDING TO THE CONSUMER SHE ALREADY HAD INSULIN ON BOARD FROM HER DINNER DOSAGE - WHICH WAS APPROXIMATELY @ 7PM. ACCORDING TO THE CONSUMER SHE EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTAKE TO HELP RAISE HER BLOOD SUGAR LEVEL. THE CONSUMER STATED, "SHE WOKE UP FEELING 'SHAKY, SWEATY AND FELT 'OUT OF IT' ." SHE PERFORMED ANOTHER BLOOD GLUCOSE TEST USING ANOTHER VIAL OF TEST STRIP WITH THE SAME LOT NUMBER GETTING A RESULT OF 86 MG/DL AT 10:30PM ON (B)(6) 2015. THE CONSUMER STATED, "BASED ON THIS RESULT AND HOW SHE FELT SHE CONSUMED TWO (2) GLUCOSE TABLETS, DRANK ORANGE JUICE AND ATE ICE CREAM." PERFORMED ADDITIONAL TESTING USING THE NEWLY OPENED VIAL AND THE SAME METER GETTING THE FOLLOWING RESULTS: (B)(6) 2015. (B)(6) STATED, "THE ABOVE RESULTS ARE ACCURATE BECAUSE THEY REFLECT THE 2 GLUCOSE TABS, ORANGE JUICE AND ICE CREAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427477 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., NA 1020214287

    Patients

    Seq Age Sex Outcome Treatment
    1 Other