BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS BLOOD GLUCOSE METER

    MDR report key: 6150535 · Received December 7, 2016

    Report

    Report Number
    3004193489-2016-00066
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 2, 2016
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    **SUPPLEMENTAL REPORT WAS INITIALLY SUBMITTED (B)(6) 2017 UNDER MANUFACTURER REPORT NUMBER: 3004193489-2019-00066-2 IN ERROR. THE CORRECT MANUFACTURER REPORT NUMBER IS: 3004193489-2016-00066-2** SOME OF THE CODES SUBMITTED UNDER THE INCORRECT MANUFACTURER REPORT NUMBER ARE NO LONGER AVAILABLE. THIS REPORT CONTAINS UPDATED CODES. THE COMPLAINT IS NOT CONFIRMED. CONSUMER DID NOT RETURN THE TEST STRIPS IN QUESTION. FAILURE ANALYSIS OF THE RETURNED NOVA MAX PLUS BLOOD GLUCOSE MONITOR REVEALED THE DEVICE TO BE WITHIN PRODUCT SPECIFICATION. NO PERFORMANCE FAILURE WAS FOUND. ALTHOUGH THE COMPLAINANT DID NOT RETURN THE BLOOD GLUCOSE TEST STRIPS IN QUESTION, QA RETAIN TEST STRIPS FROM THE SAME LOT WERE UTILIZED TO COMPLETE THE INVESTIGATION. USE OF THE CONSUMER NOVA MAX PLUS DEVICE AND THE QA STRIPS FROM THE IDENTIFIED LOT DID NOT REVEAL ANY PERFORMANCE FAILURE. ALL RESULTS OBTAINED WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    FOLLOW UP 1 SUBMITTED TO THE FDA ON 1/10/2017. TYPE OF REPORT: WAS NOT IDENTIFIED AS A FOLLOW UP #1.

    Additional Manufacturer Narrative · 1

    COMPLAINT IS NOT CONFIRMED. THE COMPLAINANT DID NOT RETURN THE GLUCOSE METER OR THE TEST STRIPS IN QUESTION. ALTHOUGH THE COMPLAINANT DID NOT RETURN THE BLOOD GLUCOSE TEST STRIPS IN QUESTION, QA RETAIN TEST STRIPS FROM THE SAME LOT WERE UTILIZED TO COMPLETE THE INVESTIGATION. RESULTS OBTAINED WERE WITHIN SPECIFICATION. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    METER TIME IS INCORRECT : ON (B)(6) 2016 @ 6:57PM 500 MG/DL - NORMAL TESTING TIME/FASTING RESULT. -ACTUAL TIME WAS 7:57AM. ON (B)(6) 2016 @ 7:44PM 550 MG/DL AS REPORTED BY THE COMPLAINANT, SHE PERFORMED A BLOOD GLUCOSE TEST AFTER EATING BREAKFAST TO CHECK IF HER GLUCOSE LEVEL WAS STILL HIGH. -ACTUAL TIME WAS 8:44AM CONSUMER STATED "...SHE ATE AN OMELET AND ORANGE JUICE AFTER THE 500 MG/DL RESULT SINCE SHE WAS HUNGRY..." THE COMPLAINANT THEN REPORTED "...SHE DID NOT TAKE HER MEDICATION BASED ON THE RESULT IN QUESTION...." SHE THEN STATED, "...SHE IS SUPPOSED TO TAKE HER MEDICINE AFTER EATING BREAKFAST EVERY MORNING..." CONCERNED ABOUT HER READINGS, THE COMPLAINANT THEN CONTACTED HER 'DOCTOR'S HELP LINE' AFTER HER 550 MG/DL READING; THE COMPLAINANT SAID, "...SHE 'FELT NORMAL AND HAD NO SYMPTOMS OF HAVING A HIGH OR LOW'. ACCORDING TO THE CONSUMER, THE DOCTOR'S HELP LINE ADVISED THE CONSUMER TO GO TO THE ER. APPROXIMATELY WITHIN 10-15 OF THE CONSUMER ENDING THE CALL WITH THE HELP LINE SHE DROVER HERSELF TO: (B)(6) MEDICAL CENTER (B)(6). ACCORDING TO THE CONSUMER THE DOCTOR CHECKED HER BLOOD GLUCOSE @ APPROXIMATELY 9:20AM BLOOD GLUCOSE 117MG/DL ON THE ER'S UNKNOWN METER. THE COMPLAINANT REPORTED "..SHE WAS NOT 'MEDICALLY TREATED BY HER DOCTOR NOR DID SHE HAVE ANYTHING TO EAT OR DRINK WHILE IN THE ER..." THE DOCTOR JUST WANTED TO MAKE SURE THE CONSUMER FELT GOOD AND PERFORMED ANOTHER BLOOD GLUCOSE TEST ABOUT 40 MINUTES AFTER CHECKING HER GLUCOSE LEVEL USING THEIR UNK METER AND RECEIVING THE 117 MG/DL READING. ACCORDING TO THE COMPLAINANT, "...SHE WAITED FOR THE RESULTS FOR APPROXIMATELY ONE HOUR AND WHEN THE RESULTS CAME BACK HER BLOOD GLUCOSE LEVEL WAS, 'NORMAL'. THE CONSUMER STATED THAT WHEN THE RESULTS CAME IN HER BG WAS NORMAL. THE CONSUMER WAS ADVISED BY HER DOCTOR TO TAKE NO ACTION THAT SHE IS DOING WELL AND TO CONTACT THE MANUFACTURER OF THE METER AND TS. THE CONSUMER WAS RELEASED RIGHT AFTER. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. 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. - STORAGE AND HANDLING KEEP THE NOVA MAX GLUCOSE TEST STRIPS VIAL TIGHTLY CLOSED WHEN NOT IN USE. TEST STRIPS SHOULD BE STORED ONLY IN THE ORIGINAL VIAL. METER AND TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED HIGHER THAN EXPECTED BLOOD GLUCOSE RESULTS. ACCORDING TO THE COMPLAINANT, "...THE DOCTOR'S HELP LINE ADVISED HER TO GO TO THE ER..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801322 NOVA MAX PLUS BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW NOVA BIOMEDICAL CORP., N/A 1021316111

    Patients

    Seq Age Sex Outcome Treatment
    1