BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4972901 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00104
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 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 COULD NOT BE CONFIRMED. THE CONSUMER DID NOT RETURN THE TEST STRIPS IN QUESTION. FAILURE ANALYSIS OF THE RETURNED NOVA MAX BLOOD GLUCOSE METER REVEALED THE DEVICE TO BE WITHIN PRODUCT SPECIFICATION NO PERFORMANCE FAILURE WAS FOUND. ALTHOUGH THE CONSUMER 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 DEVICE AND THE QA STRIPS FROM THE IDENTIFIED LOT DID NOT REVEAL ANY PERFORMANCE FAILURE. 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

    THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL. TEST STRIP LOT # 1020214204 EXPIRATION DATE: 07/2016 CONTROL SOLUTION LOT #1030313121 RANGE: 82-127 MG/DL. 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

    PHARMACIST CALLED ON BEHALF OF CONSUMER WHO REPORTED DISCREPANCIES IN THEIR BG READINGS LATELY. CONSUMER WAS NOT PRESENT TO INDICATE EXACTLY WHICH READINGS WERE BEING QUESTIONED SO THE LAST 3 BG RESULTS WERE PULLED DIRECTLY FROM THE METER MEMORY. IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 273 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED TWO ADDITIONAL TESTS USING THE SAME METER AND STRIPS FROM THE SAME VIAL GETTING THE FOLLOWING RESULTS OF 314 MG/DL AND 167 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER CONTROL TESTED THEIR TEST STRIPS WHEN THEY WERE OPENED AND THE TEST STRIPS CONTROL SOLUTION FELL INTO RANGE. AN ADDITIONAL CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING SHOWING THE TEST STRIPS TO FALL IN RANGE AGAIN. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505409 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 102014204

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK