BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 5056319 · Received September 4, 2015

    Report

    Report Number
    3004193489-2015-00124
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 27, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020214287, EXPIRATION DATE: 10/31/2016, 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.

    Description of Event or Problem · 1

    (B)(6) CALLED IN CONCERNED ABOUT CONSUMER'S HIGH BG RESULTS. RESULTS IN QUESTION WERE OBTAINED DIRECTLY FROM THE METER MEMORY. (B)(6) 2015 @ 10:06 AM BG 203 MG/DL. CONSUMER FELT BG RESULT WAS TOO HIGH AND WAS TAKEN TO THE ER BY HIS WIFE CONSUMER WAS TESTED AT THE HOSPITAL, LAB TEST - (B)(6) 2015 @ APPROX. 2:45PM BG 96 MG/DL (LAB RESULT). CONSUMER WAS GIVEN A JUICE AND RELEASED WITHOUT ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587992 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITITOR NBW NOVA BIOMEDICAL CORP., N/A 1020214287

    Patients

    Seq Age Sex Outcome Treatment
    1 Other