BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4972898 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00112
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 25, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S COMPLAINT IS CONFIRMED. EVALUATION OF THE RETURNED BLOOD GLUCOSE TEST STRIPS READ HIGH OUT OF RANGE. THE ROOT CAUSE IS ATTRIBUTED TO THE CONSUMER'S STORAGE AND HANDLING OF THE TEST STRIPS AS EVIDENCED BY THE WEIGHT OF THE RETURNED VIAL FAILING THE WEIGHT TEST. A FAILURE OF THIS NATURE IS CONSISTENT WITH A COMPROMISED VIAL BY EXPOSURE TO HUMIDITY AND/OR FLUID. THIS FINDING IS FURTHER SUPPORTED BY THE RESULTS OF THE RETAIN STRIP LOT TESTING WHICH CONFIRMS THE RETAIN STRIPS TO PERFORM WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL. TEST STRIP LOT # 1020215050 EXPIRATION DATE: 02/2017 CONTROL SOLUTION LOT NONE. PER LABEL COPY/ PACKAGE INSERT. UNEXPECTED RESULTS. 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. 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 EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE CONCERNED WITH HIS HIGH BLOOD GLUCOSE RESULTS. THE CONSUMER REPORTED HE PERFORMED A BLOOD GLUCOSE TEST ON (B)(6) 2015 AT 11:56PM GETTING A RESULT OF 305 MG/DL. APPROXIMATELY AN HOUR LATER, THE CONSUMER WENT TO THE EMERGENCY ROOM TO HAVE HIS BLOOD GLUCOSE LEVEL CHECKED BECAUSE HE DID NOT BELIEVE THE 305 MG/DL WAS AN ACCURATE RESULT. 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. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505438 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020215050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK