BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRA FERTILITY CONFIRM PDG WAND

    MDR report key: 12583682 · Received October 5, 2021

    Report

    Report Number
    MW5104424
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 26, 2021
    Report Date
    October 2, 2021
    Manufacturer
    QUANOVATE TECH INC.
    Product Code
    QKE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MY PATIENT CAME TO ME AND WAS (B)(6) PREGNANT AND BLEEDING HEAVILY. SHE WAS DOUBLED OVER IN PAIN AND WAS EXPERIENCING TERMINATION OF HER PREGNANCY. WE GAVE HER AN ULTRASOUND AND ORDERED BLOOD WORK TO MEASURE BETA HCG AND PROGESTERONE. RESULTS CAME BACK INDICATING PROGESTERONE WAS 2.8 NG/ML AND HCG LEVELS WERE 3,456. ULTRASOUND INVESTIGATION INDICATED THAT THERE WAS A 2.3 MM GESTATIONAL SAC AND A FETAL POLE, HOWEVER, NO HEARTBEAT WAS DETECTED. UPON INVESTIGATION, THE PATIENT TOLD ME SHE HAD BEEN MONITORING HER PREGNANCY WITH THE MIRA DEVICE. IT MEASURES PROGESTERONE. THE DEVICE INDICATED THAT HER PROGESTERONE WAS HIGH SO SHE IGNORED SIGNS THAT HER PREGNANCY WAS FAILING. BY THE TIME SHE REACHED A DOCTOR, IT WAS TOO LATE, SHE HAD LOST THE PREGNANCY. INCORRECT READINGS FROM THE MIRA LED TO THE DEATH OF THIS WOMAN'S FETUS. FETUS DATE OF DEATH WAS (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472273 MIRA FERTILITY CONFIRM PDG WAND IMMUNOASSAY, PREGNANEDIOL GLUCURONIDE, OVER THE COUNTER QKE QUANOVATE TECH INC. MIRA CONFIRM WAND 2021080904

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR