inforMED
MalfunctionQKE

MIRA FERTILITY PLUS WANDS

Received Apr 28, 2021 · Event occurred Apr 21, 2021

Report MW5101072 · MDR key 11744596

Device

Generic name

Immunoassay, Pregnanediol Glucuronide, Over The Counter

Catalog number

LH AND ESTROGEN WANDS

Lot number

2021010305

Product problems

  • Device Displays Incorrect Message
  • Therapeutic or Diagnostic Output Failure

Patient

32 YR

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

FAILED FERTILITY TREATMENT; I'M DOING FERTILITY TREATMENTS AT MY FERTILITY CLINIC AND USING THE MIRA DEVICE AT HOME TO MONITOR MY CYCLE. I PURCHASED A BOX OF MIRA FERTILITY PLUS WANDS IN MARCH 2021 AND HAVE BEEN GETTING ERROR MESSAGES THAT THEY DIDN'T WORK. I REACHED OUT TO MIRA SUPPORT AND THEY TOLD ME THAT THERE IS A KNOWN ISSUE WITH THE LOT OF TESTS I GOT. BY THE TIME THEY RESPONDED, I WAS WELL INTO MY CYCLE AND MISSED MY FERTILE WINDOW. THIS CAUSED ME TO SPEND THOUSANDS OF DOLLARS ON MEDICATIONS WITHOUT CONCEPTION SINCE MIRA DEVICE TOLD ME I WAS NOT FERTILE BUT THE DOCTOR DID A BLOOD DRAW AND I HAD ALREADY PASSED MY FERTILE WINDOW. I'M NOT EXACTLY SURE WHY MIRA HAS A KNOWN ISSUE WITH THEIR PRODUCTS BUT IT STILL SELLING THEM. SHOULDN'T THEY BE RECALLED SINCE THEY DON'T WORK? I POSTED MY PROBLEM TO THEIR FACEBOOK SUPPORT GROUP AND 6 OTHER WOMEN HAD THE SAME PROBLEM AS ME. THIS COMPANY IS SELLING WORTHLESS PRODUCTS AND IT CAUSES WOMEN LIKE ME TO MISS OUR FERTILITY WINDOWS. THEY ARE VERY EXPENSIVE TOO. CAN ANYTHING BE DONE TO MAKE MIRA RECALL THEIR DEFECTIVE PRODUCT? FDA SAFETY REPORT ID # (B)(4).