BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS BLOOD GLUCOSE MONITOR

    MDR report key: 6036112 · Received October 18, 2016

    Report

    Report Number
    3004193489-2016-00059
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 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 · 1

    ACCORDING TO THE COMPLAINANT, "...DID NOT TAKE HER VITAMINS FOR THE PAST TWO (2) DAYS AND HAS BEEN TAKING A NEW SUPPLEMENT...". THE COMPLAINANT REPORTED, "...SHE 'TOOK' AN EXTRA 1000MG PILL OF METFORMIN AFTER NOTICING HER BLOOD GLUCOSE LEVELS DID NOT DROP AFTER HER INITIAL NORMAL DOSE OF 1000MG OF METFORMIN..." SHE ALSO REPORTED, "SHE DID NOT EAT BREAKFAST AS SHE WAS CONCERNED ABOUT HER BLOOD GLUCOSE LEVELS. COMPLAINANT HAD A NEW UNOPENED VIAL OF TEST STRIPS LOT# 1020416003, EXP. DATE 2018/01, STORED PROPERLY, AND PERFORMED A BLOOD GLUCOSE TEST USING PROPER TECHNIQUE: GETTING A RESULT OF 165 MG/DL ON (B)(6) 2016 AT 2:55 PM. VISUAL AS WELL AS CHEMICAL EVALUATION (BY TESTING WITH CONTROL SOLUTION) OF THE RETURNED GLUCOSE TEST STRIPS REVEALED 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 SUPPORTED BY THE RESULTS OF THE RETAIN STRIP TESTING WHICH INDICATES THE PERFORMANCE OF THE RETAIN STRIPS ARE WITHIN PRODUCT SPECIFICATION. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    CONSUMER CALLED IN CONCERNED ABOUT HIGH BLOOD GLUCOSE READINGS THIS MORNING. TIME AND DATE STORED IN THE METER ARE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689590 NOVA MAX PLUS BLOOD GLUCOSE MONITOR BLOOD GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020215050

    Patients

    Seq Age Sex Outcome Treatment
    1