BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INITO FERTILITY MONITOR

    MDR report key: 23907481 · Received December 29, 2025

    Report

    Report Number
    MW5181304
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 18, 2025
    Manufacturer
    CENTUM ELECTRONICS LIMITED
    Product Code
    NGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER TRYING USING THE DEVICE FOR THE FIRST TIME, IT SHOWED AN ERROR IN THE READING, I TRIED MANY TIMES WITHOUT SUCCESS, I CONTACTED THE MANUFACTURER VIA PHONE AND EMAIL WITHOUT SUCCESS, THEY HAVE NOT OFFERED ANY SOLUTION FOR THE DEVICE MALFUNCTIONING, IT DOES NOT READ ANY STRIP. VIA EMAIL AND PHONE CALL THEY REQUEST ME TO WAIT 24 HRS, AFTER THE TIME HAS PASSED, THEY DO NOT CALL BACK OR EMAIL WITH ANY NEW INFORMATION, I HAVE NEEDED TO CALL THEM BACK WHERE THEY JUST REQUEST FOR ME TO WAIT 24 HRS MORE. THE ANDROID DEVICE JUST DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462266 INITO FERTILITY MONITOR TEST, LUTEINIZING HORMONE (LH), OVER THE COUNTER NGE CENTUM ELECTRONICS LIMITED IWR-V-03

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other LETROZOLE.