BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZO TEST STRUOS

    MDR report key: 2654768 · Received July 12, 2012

    Report

    Report Number
    MW5026136
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    March 2, 2009
    Report Date
    April 13, 2009
    Manufacturer
    SIEMENS DIAGNOSTICS
    Product Code
    CEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT USED TWO DIFFERENT TESTS STRIPS AND THE COLOR DIDN'T CHANGE RESULTING IN THE DEVICE NOT DETECTING A UTI. PT WAS ULTIMATELY DIAGNOSED WITH UTI UPON VISITING HER PHYSICIAN. AMERIFIT IS CURRENTLY REVIEWING ITS FILES FOR THE LOT OF PRODUCT NOTED IN THIS REPORT. IT IS POSSIBLE TO RECEIVE FALSE NEGATIVES WHEN THIS PRODUCT IF NOT USED IN ACCORDANCE WITH THE PACKAGE INSERT INSTRUCTIONS. THE INSTRUCTIONS CLEARLY STATE THAT AFTER TESTING TWICE WITH NEGATIVE RESULTS, BUT STILL SHOWING SYMPTOMS, TO CONTACT PHYSICIAN. UPON COMPLETION OF ITS INVESTIGATION, AMERIFIT WILL CONTACT THE COMPLAINANT DIRECTLY. AMERIFIT HAS AGREED TO REFUND THE PURCHASE PRICE OF THE PRODUCT TO THE PT. MANUFACTURE DATE: 04/2008. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZO TEST STRUOS UTI DETECTION (LEUCOCYTES/NITRITES) CEN SIEMENS DIAGNOSTICS 8D14D-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other