inforMED
MalfunctionNGE

INITO FERTILITY MONITOR

Received Dec 29, 2025 · Event occurred Dec 15, 2025

Report MW5181304 · MDR key 23907481

Device

Generic name

Test, Luteinizing Hormone (lh), Over The Counter

Model number

IWR-V-03

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Therapeutic or Diagnostic Output Failure

Patient

30 YR · Female

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

Narrative

Description of Event or Problem

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.