BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 5087341 · Received September 18, 2015

    Report

    Report Number
    3004193489-2015-00130
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 11, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S COMPLAINT COULD NOT BE CONFIRMED. THE CONSUMER DID NOT RETURN THE REPORTED GLUCOSE METER - AND THE TEST STRIPS WERE UNKNOWN. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. METER WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CONSUMER CALLED IN REPORTING AN INCIDENT LAST FRIDAY (B)(6) WHEN HE HAD A REACTION AFTER GIVING HIMSELF INSULIN BASED ON A HIGH BG RESULT. BG RESULTS PULLED DIRECTLY FROM THE METER (B)(6) 2015 AT 2:29 AM BG 450-TOOK 75 UNITS AFTER THIS RESULT. AT 4:46 AM BG 296. AT 6:49 AM BG 158. AT 8:07 AM BG 147. BEGAN FEELING VERY BAD, SWEATING PROFUSELY AND COULD NOT WALK. FELT HIS BG WAS VERY LOW. DRANK A SODA AND HAD SEVERAL COOKIES. HE TESTED HIS BG AGAIN A FEW HOURS LATER: (B)(6) 2015 AT 12:32 PM BG 247. THE CONSUMER ALLEGES A CONTROL SOLUTION TEST WAS PERFORMED AS INSTRUCTED IN THE DIRECTIONS FOR USE AND REPORTED THE RESULT WAS WITHIN RANGE. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION WITH HIM AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620610 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other