BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3960601 · Received July 16, 2014

    Report

    Report Number
    3004193489-2014-00058
    Event Type
    Other
    Date Received
    July 16, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020814091, EXPIRATION DATE: 04/2016. CONTROL SOLUTION LOT: 1030113086, RANGE: 82-127 MG/DL. 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 224 MG/DL ON HER NOVA MAX BLOOD GLUCOSE METER. APPROXIMATELY AN HOUR LATER THE CONSUMER DID NOT BELIEVE THAT RESULT TO BE ACCURATE AND WENT TO A CLINIC TO SEEK MEDICAL ASSISTANCE BECAUSE SHE "FELT STRANGE." AT THE CLINIC THEY PERFORMED A BLOOD GLUCOSE TEST ON THEIR UNK BRAND OF GLUCOSE METER GETTING A RESULT OF 93 MG/DL. THE CONSUMER LEFT THE CLINIC WITHIN 15 MINS AND HAD A SNACK. DURING THE CALL TO CUSTOMER STRIPS FOR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTSUPPORT, THE CONSUMER ADMITTED THAT SHE DOES NOT RUN REGULAR CONTROL SOLUTION TESTS ON THEIR TEST ROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL OUT OF RANGE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415926 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020814091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention