BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3871958 · Received April 22, 2014

    Report

    Report Number
    3004193489-2014-00025
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020214027, EXPIRATION DATE: 01/2016. CONTROL SOLUTION LOT # 1030312083, RANGE: 82-127 MG/DL. 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 BY THE CONSUMER THAT, "SHE WAS CONCERNED ABOUT SOME OF THE HIGH READINGS SHE HAS BEEN GETTING WHEN USING HER NOVA MAX PLUS METER". THE CONSUMER REPORTED THAT SHE RECEIVED A RESULT OF 304 MG/DL ON HER BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER AND STRIPE FROM THE SAME VIAL GETTING THE FOLLOWING RESULT OF 139 MG/DL. AN HOUR LATER PERFORMED BACK TO BACK TESTS AGAIN GETTING A 63 MG/DL AND 163 MG/DL. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243613 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020214027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK