BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INITO HORMONE MONITOR

    MDR report key: 23838978 · Received December 18, 2025

    Report

    Report Number
    MW5180805
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 11, 2025
    Manufacturer
    INITO LLC / INITO HEALTH TECH PRIVATE LIMITED
    Product Code
    NGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE USED INITO HORMONE TRACKER FROM THE END OF MAY TILL MID (B)(6). I HAD GOOD RESULTS UNTIL THE BEGINNING OF (B)(6) WHEN ESTROGEN WAS REPORTING HIGHER THAN POSSIBLE FOR ME. TRIPLE WHAT IS NORMAL FOR ME - A LATE-PERIMENOPAUSAL WOMAN. I REPORTED IT SEVERAL TIMES TO CUSTOMER SUPPORT WHO DISMISSED ME AND SAID THE DEVICE IS FINE AND THE STRIPS ARE NORMAL. BASICALLY, TELLING ME IT'S MY PROBLEM. I BOUGHT A MIRA DEVICE AND NOW I'M GETTING ACCURATE RESULTS FROM IT. ESTROGEN LEVELS ARE WITHIN A NORMAL RANGE. I TESTED THE SAME URINE SAMPLE WITH INITO AND MIRA AND IT SHOWED THE DRASTIC DIFFERENCE. I SUBMITTED THIS INFO TO CUSTOMER SERVICE AND THEY SAID THEY CAN'T COMMENT ON OTHER DEVICES RESULTS. I HAVE ALL OF THE DATA TRACKED IN A SPREADSHEET, IF NEEDED. INITO REFUSED TO REFUND ME FOR THE DEVICE. SO, I'M REPORTING IT HERE. I HAVE SCREEN SHOTS AND DATE FOR 3 WEEKS OF FAULTY TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282195 INITO HORMONE MONITOR TEST, LUTEINIZING HORMONE (LH), OVER THE COUNTER NGE INITO LLC / INITO HEALTH TECH PRIVATE LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female .0125 ESTRADIOL PATCH| 100MG MICRONIZED PROGESTERONE| COQ10| MAGNESIUM| MULTIVITAMIN| VITAMIN D