BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK BLOOD GLUCOSE MONITOR

    MDR report key: 6034275 · Received October 17, 2016

    Report

    Report Number
    3004193489-2016-00057
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 26, 2016
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MR. (B)(6) STATED WHEN EMT'S ARRIVED THEY DID NOT HAVE A GLUCOMETER WITH THEM AND HAD HER TESTED OUTSIDE AFTER A 3RD EMT ARRIVED WITH A GLUCOMETER AND THE RESULT WAS 21 MG/DL CALLER COULD NOT REMEMBER ANY DETAILS ABOUT TREATMENT ADMINISTERED AT HOME BEFORE CONSUMER WAS TAKEN TO HOSPITAL. MR. (B)(6) DID REPORT THAT WHILE THE COMPLAINANT WAS IN THE HOSPITAL SHE WAS GIVEN, "GLUCOSE IV." THE COMPLAINANT WAS RELEASED FROM THE HOSPITAL ON SATURDAY WITH SOME MEDICATION AND INSTRUCTION TO FOLLOW UP WITH HER DOCTOR. MR. (B)(6) STATED HE WAS TAKING HIS WIFE TO THERAPY AND COULD NOT GO THROUGH METER MEMORY AND PROVIDE MORE INFORMATION. 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. THE 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 NOVAMAX LINK METER GLUCOSE MONITORING DEVICE PERFORMED WITHIN SPECIFICATION. THE GLUCOSE TEST STRIP VIAL RETURNED BY THE COMPLAINANT CONTAINED 11 TEST STRIPS. THE COMPLAINANT REPORTED THEY COMBINE TEST STRIPS FROM MULTIPLE VIALS INTO ONE VIAL. COMBINING TESTS STRIPS WOULD COMPROMISE THE INTEGRITY OF THE STRIPS. THE STRIPS COULD NOT BE TESTED AS WE ARE UNABLE TO CONFIRM OR IDENTIFY THE LOT NUMBERS CONTAINED IN THE RETURNED VIAL. QA RETAIN TEST STRIPS WERE UTILIZED TO COMPLETE THE INVESTIGATION ON THE REPORTED TEST STRIP LOT NUMBER. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. 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

    COMPLAINANT'S HUSBAND, MR. (B)(6), CALLED INTO CUSTOMER CARE TO REPORT AN INCIDENT WITH HIS WIFE. THE CALLER REPORTED "...LAST THURSDAY (B)(6) THE COMPLAINANT WOKE UP AND WAS NOT FEELING VERY WELL..." ACCORDING TO THE CALLER, "...SHE TESTED HERSELF, HAD BREAKFAST AND TOGETHER THEY LEFT THE HOUSE TO PICK UP SOME MEDICATION AT THE PHARMACY. WHEN THEY ARRIVED AT THE PHARMACY, "...SHE WAS FEELING 'TIRED' ENOUGH THAT SHE ASKED TO STAY IN THE CAR WHILE HE WENT IN TO GET THE MEDICATION. THE CALLER THEN REPORTING AFTER RETURNING HOME THE COMPLAINANT WAS STILL 'NOT FEELING GOOD' AND SHE DECLINED BEING TAKEN TO THE HOSPITAL; SHE WANTED TO REST FOR SOMETIME...." MR. (B)(6) CHECKED ON HIS WIFE A MOMENT LATER AND FOUND HER ALMOST UNRESPONSIVE, HE THEN CALLED 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686945 NOVA MAX LINK BLOOD GLUCOSE MONITOR BLOOD GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020215082

    Patients

    Seq Age Sex Outcome Treatment
    1