BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOMETER

    MDR report key: 4945999 · Received July 22, 2015

    Report

    Report Number
    MW5044810
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 20, 2015
    Report Date
    July 22, 2015
    Manufacturer
    NOVA MAX
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT CAME TO CLINIC REPORTING HIGHER GLUCOSE READINGS ON THE NOVA MAX MACHINE. PT REPORTS RECEIVING 300+ ON HIS NOVA MAX GLUCOMETER MACHINE AND COMPARED IT WITH A LOCAL PHARMACY TESTING WHICH SHOWED 110. PT DENIED STORING TEST STRIPS IN EXTREME TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476748 NOVA MAX GLUCOMETER TEST STRIP NBW NOVA MAX 1020215082
    476792 NOVA MAX GLUCOMETER GLUCOMETER NBW NOVA MAX NOVA MAX GLUCOMETER

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR GLUCOMETER TEST STRIP FROM NOVA MAX