MalfunctionNGE

INITO FERTILITY MONITOR

Received Sep 5, 2024 · Event occurred Sep 1, 2024

Report MW5159276 · MDR key 20160140

Device

Generic name

Test, Luteinizing Hormone (lh), Over The Counter

Manufacturer

Centum Electronics Limited

Patient

35 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.