BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 5189198 · Received October 29, 2015

    Report

    Report Number
    3004193489-2015-00153
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    October 24, 2015
    Report Date
    October 24, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020414147, EXPIRATION DATE: 05/31/2016. CONTROL SOLUTION LOT # 1030113176, CSR 82-127 MG/DL. 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. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S ALLEGED DEFICIENCY COULD NOT BE CONFIRMED. ALTHOUGH THE REPORTED RESULTS WERE FOUND IN THE MEMORY OF THE RETURNED DEVICE, FAILURE ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THE NOVA MAX LINK GLUCOSE MONITORING DEVICE PERFORMED WITHIN SPECIFICATION. THE CUSTOMER RETURNED BLOOD GLUCOSE TEST STRIP FROM THE LOT IN QUESTION. VISUAL AS WELL AS CHEMICAL EVALUATION (BY TESTING WITH CONTROL SOLUTION) WAS NOT ABLE TO REPLICATE THE ALLEGED ISSUE AS THE PERFORMANCE TESTING REVEALED THE STRIP TO PERFORM WITHIN SPECIFICATION AS WELL. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    CONSUMER'S HUSBAND CALLED IN REPORTING A DISCREPANCY BETWEEN THE EMT'S METER AND HER NML. CONSUMER HAD A 'HYPOGLYCEMIC EVENT THIS MORNING'. SHE TESTED HER BG THIS MORNING: (B)(6) 2015 AT 11:22 AM BG 52 MG/DL. CONSUMER STATED HER " BLOOD GLUCOSE LEVELS SEEMED NORMAL TODAY EXCEPT FOR THIS RESULT." HER HUSBAND NOTICED SHE WAS 'OUT OF IT' AS THEY WATCHED TV. HE TRIED TO GIVE HER ORANGE JUICE AND SHE WOULDN'T TAKE IT. THEY LIVE IN AN ASSISTED LIVING HOME AND HE CALLED THE AIDES UP. THEY THEN CALLED THE EMTS WHO ARRIVED AT 12:10 PM. THEY TESTED HER WITH THEIR METER AND RECEIVED A 28. THEY TESTED HER FROM THE SAME SITE ON HER NML: (B)(64) 2015 AT 12:17 PM BG 43 MG/DL. THE EMT'S GAVE HER ORANGE JUICE, SOME GLUCOSE GEL AND A SANDWICH. THEY TESTED HER AGAIN BEFORE THEY LEFT AT 12:45 PM AND RECEIVED A 79 ON THEIR METER. SHE WAS NOT TRANSPORTED TO THE HOSPITAL. SHE TESTED AGAIN WITH HER NML A FEW MINUTES LATER: (B)(6) 2015 AT 12:48 PM BG 49 MG/DL. ACCORDING TO THE CONSUMER, A CONTROL SOLUTION TEST WAS PERFORMED ON TEST STRIPS IN QUESTION LAST WEEK AND THE RESULT WAS 116 MG/D RESULT WAS WITHIN RANGE; HOWEVER, THAT RESULT COULD NOT BE FOUND IN THE METER MEMORY DUE TO THE NUMBER OF TESTS TAKEN RECENTLY, BG TESTS PERFORMED ACCORDING TO THE NMP OWNERS GUIDE, NO RECENT CHANGES IN DIET, MEDICATION, EXERCISE, OR HEALTH, CONSUMER RECEIVES INSULIN FROM HER PUMP ALL DAY-SHE IS VERY BRITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720590 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020414147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other