BEUDAMED
    FDA Adverse Event Other Summary report: N

    AZO

    MDR report key: 2654769 · Received July 12, 2012

    Report

    Report Number
    MW5026137
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    August 13, 2009
    Report Date
    September 3, 2009
    Manufacturer
    SIEMENS DIAGNOSTICS, INC.
    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

    THE COLORS ON THE UTI TEST PADS DID NOT MATCH ANY OF THE COLORS ON THE BOTTLES. THE WBC PAD TURNED PINK AND THE NITRITE PAD REMAINED THE SAME. CONSUMER WENT TO DR AND WAS DIAGNOSED WITH UTI. AMERIFIT IS INVESTIGATING THIS COMPLAINT PURSUANT TO ITS INTERNAL PROCEDURES WHICH INCLUDED A REVIEW OF THE PRODUCT RELEASE FILE AND RETAIN SAMPLES. FROM THE INFO PROVIDED IT APPEARS THAT THE CONSUMER MAY HAVE BEEN COMPARING THE TEST PADS INCORRECTLY TO THE COLOR CHART. THE TEST STRIPS MAY HAVE BEEN USED IN A MANNER NOT DIRECTED IN THE PACKAGE INSERT. THE CONSUMER WAS DIAGNOSED BY A HEALTH PROFESSIONAL WITH A UTI SO IT COULD BE THAT NITRITES WEREN'T PRESENT IN THE URINE AT THE TIME THE AZO TEST STRIPS WERE USED. WE'RE NOT ABLE TO OBTAIN ADD'L INFO ON WHAT TEST(S) WERE USED TO DIAGNOSE A UTI BY CONSUMER'S HEALTH PROFESSIONAL. SHOULD ADD'L INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. PMA/510(K) K960888. DEVICE MANUFACTURE DATE: 04/2008. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZO AZO TEST STRIPS CEN SIEMENS DIAGNOSTICS, INC. 8D14DA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other