BEUDAMED
    FDA Adverse Event Other Summary report: N

    AZO TEST STRIPS

    MDR report key: 2654770 · Received July 12, 2012

    Report

    Report Number
    MW5026138
    Event Type
    Other
    Date Received
    July 12, 2012
    Report Date
    June 19, 2009
    Manufacturer
    SIEMENS DIAGNOSTICS, INC.
    Product Code
    CEN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT USED TEST AT HOME AND RECEIVED A NEGATIVE RESULT. WENT TO DR WHO DIAGNOSED UTI. PT TRIED TEST AT HOME AGAIN AND STILL RECEIVED A NEGATIVE RESULT. AMERIFIT WILL INVESTIGATE THIS COMPLAINT PURSUANT TO ITS INTERNAL SOP'S. THERE ARE INSTANCES WHEN A NEGATIVE RESULT MAY OCCUR IF THE DEVICE IS NOT USED PROPERLY OR IF THE PT DOESN'T CLEANSE PROPERLY BEFORE USING THE TEST. MEDICATIONS MAY INTERFERE WITH ACTUAL RESULTS AND SOME PTS BODIES DO NOT ALWAYS PRODUCE NITRITES WHEN AN UTI OCCURS. IN ADDITION, THE DEVICE IN QUESTION TESTS FOR NITRATES AND LEUKOCYTES. THERE ARE UTI'S THAT CAN BE CAUSED BY OTHER BACTERIA THAT WOULD NOT CAUSE A POSITIVE RESULT FOR EITHER MEASURED COMPONENT. SHOULD ADD'L INFO BECOME AVAILABLE THAT IS IMPORTANT TO ITS INVESTIGATION OF THIS COMPLAINT, AN UPDATED REPORT WILL BE FILED WITH FDA. AMERIFIT HAS PROVIDED THE PT WITH REPLACEMENT PRODUCT AT THEIR REQUEST. MANUFACTURE DATE: 07/2008. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZO TEST STRIPS URINARY TRACT INFECTION TEST CEN SIEMENS DIAGNOSTICS, INC. 8G01D-A-035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other