BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4886490 · Received July 1, 2015

    Report

    Report Number
    3004193489-2015-00080
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 8, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020215050 EXPIRATION DATE: 2/201 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.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE TO REPORT HER CONCERN ABOUT, "THE PERFORMANCE OF HER NOVA MAX PLUS METER." THE CONSUMER REPORTED THAT (B)(6) 2015 AT 5:30ON SHE PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 263 MG/DL. THE CONSUMER ADMINISTERED 8 UNITS BASED ON THIS RESULT AND AT APPROXIMATELY 8:30PM WAS FOUND UNCONSCIOUS BY HER DAUGHTER WHO CALLED THE EMTS. WHEN THE EMTS ARRIVED THEY PERFORMED A BLOOD GLUCOSE TEST ON THIS CONSUMER USING THEIR UNKNOWN BRAND METER GETTING A RESULT OF 20 MG/DL. ACCORDING TO THE CONSUMER, THE EMTS PERFORMED ANOTHER BLOOD GLUCOSE TEST USING THE CONSUMER'S METER AND STRIPS GETTING A RESULT OF 80 MG/DL. CONSUMER WAS GIVEN AN IV OF GLUCOSE BY EMT'S. EMT'S ADVISED CONSUMER TO GO TO THE ER BUT SHE DECLINED; STATED "SHE DID NOT WANT TO HAVE TO SPEND SEVERAL HOURS IN THE ER'S." ACCORDING TO THE CONSUMER, SHE WAS "ADVISED BY THE EMT'S TO HAVE A PEANUT BUTTER SANDWICH TO RAISE HER BLOOD SUGAR." WHEN THEY WERE LEAVING. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER DECLINE TO PERFORM ANY TROUBLESHOOTING WITH THE PRODUCT IN QUESTION, JUST WANTED HER METER AND STRIPS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427406 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020215050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other