BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX TEST STRIPS

    MDR report key: 4323190 · Received December 5, 2014

    Report

    Report Number
    MW5039465
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    September 9, 2014
    Report Date
    December 5, 2014
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES HAS BEEN RECHECKING BG WITHIN 1 MINUTE TO DOUBLE CHECK RESULT AND NOTICED THAT THE VALUE IS DIFFERENT (84 --> 193, 152 -->84, 212-->163, 193-->160). PT ALSO EXPRESSES CONCERN THAT GLUCOMETER IS NOT WORKING PROPERLY. IN CLINIC, USE CONTROL SOLUTION AND APPLIED TO PATIENT'S TEST STRIP. THE RESULT WAS 171 WHICH WAS NOT WITHIN GIVEN RANGE BY THE MANUFACTURER OF 82-127 MG/DL. ALSO TESTED THE PATIENT'S METER USING CLINIC TEST STRIP AND THE RESULT WAS WITHIN GIVEN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786558 NOVA MAX TEST STRIPS NOVA MAX TEST STRIPS NBW NOVA BIOMEDICAL 1020214027

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR