BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3032954 · Received April 1, 2013

    Report

    Report Number
    3004193489-2013-00030
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 29, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 'HI' (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED TWO ADDITIONAL TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS OF 'HI' AND 101 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER ALLEGES HAVING CONTROL TESTED HER TEST STRIPS WHEN THEY WERE OPENED AND THAT THE TEST STRIPS CONTROL SOLUTION FELL INTO RANGE. THE CONSUMER DECLINED TO PERFORM ANY TROUBLESHOOTING WHILE ON THE LINE WITH CUSTOMER SUPPORT. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132554 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020412255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK