BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX MONITOR

    MDR report key: 3050232 · Received April 5, 2013

    Report

    Report Number
    3004193489-2013-00034
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    April 4, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 ON (B)(6) 2013, THAT A CONSUMER REC'D A RESULT OF 334 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULT OF 134 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. 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 READING WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER WILL BE RETURNED FOR EVALUATION. THE TEST STRIPS WILL NOT BE RETURNED, THEY HAVE BEEN EXHAUSTED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139924 NOVA MAX MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020212207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK