BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INITO FERTILITY MONITOR

    MDR report key: 20160140 · Received September 5, 2024

    Report

    Report Number
    MW5159276
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 1, 2024
    Manufacturer
    CENTUM ELECTRONICS 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

    INITO FERTILITY MONITOR - CLASS 1 MEDICAL DEVICE. I HAVE BEEN USING THIS DEVICE FOR 2 MONTHS AND AM PART OF A FACEBOOK AND REDDIT SUPPORT GROUP FOR THIS PRODUCT. IT SEEMS THAT THERE IS A BUG IN THE SOFTWARE WHERE SOME USERS ARE CORRECTLY HAVING A PROCESSING TIME OF 600 SECONDS, BUT A BUG IN THEIR SOFTWARE EFFECTING SOME USERS ONLY PROCESS THE TEST IN 300 SECONDS, INCORRECTLY. IT SEEMS LIKE THIS IS AFFECTING ABOUT HALF THE USERS. THE COMPANY SHOULD IMMEDIATELY FIX THIS BUG SO THAT TEST RESULTS ARE ACCURATE AS WOMEN ARE RELYING ON THIS TEST TO INFORM THEIR FERTILITY HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296594 INITO FERTILITY MONITOR TEST, LUTEINIZING HORMONE (LH), OVER THE COUNTER NGE CENTUM ELECTRONICS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other