BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEST STRIPS URINARY TRACT INFECTION

    MDR report key: 23542285 · Received November 12, 2025

    Report

    Report Number
    MW5178808
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    November 9, 2025
    Report Date
    November 10, 2025
    Manufacturer
    AZO / I-HEALTH, INC.
    Product Code
    LJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS HAVING BLADDER PAIN STARTING THURSDAY. TOOK A UTI TEST FROM AZO THAT APPEARED NEG. WAS STILL HAVING PAIN BY SUNDAY SO PURCHASED ANOTHER TEST. THE TOP HAD A TAD BIT OF PINK BUT NOTICED THE DIRECTIONS DIDN'T MAKE SENSE. ASSUMED IT WAS NEGATIVE SINCE THE COLORS DIDN'T MATCH. STILL HAVING PAIN MONDAY, SO WENT TO TAKE THE TEST AGAIN AND NOTICED... THE BOX SAYS THE NITRITES PAD IS ON TOP AND THE LEUKOCYTES PAD IS ON THE BOTTOM. THE INSIDE PACK DIRECTIONS SAY THE OPPOSITE. LEUKOCYTES PAD ON TOP AND NITRITES PAD ON BOTTOM. IT'S NOW 9:30AM ON MONDAY AND HAVE TO BE AT WORK IN 2 HRS AND PROBABLY DO HAVE A BLADDER INFECTION. WHICH I COULD HAVE DEALT WITH SUNDAY WHEN I DON'T HAVE WORK. BUT NOW WILL HAVE TO WAIT TILL TOMORROW AM SINCE I WORK TILL 8 AND NO URGENT CARES ARE OPEN THEN. JUST ANNOYING AND WANTED TO MAKE SURE IT'S FIXED FOR OTHERS. PT CODES: 1994, 2120. DEVICE CODE: 2956. REF REPORT: MW5178809.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120133 TEST STRIPS URINARY TRACT INFECTION TEST, URINE LEUKOCYTE LJX AZO / I-HEALTH, INC. 25199ASM12

    Patients

    Seq Age Sex Outcome Treatment
    1 Female