BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 17948898 · Received October 17, 2023

    Report

    Report Number
    3008573045-2023-00046
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 8, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT SUGGESTED THERE WERE NO MEDICAL INTERVENTION OR TREATMENT PROVIDED LOT NUMBER HAS NOT BEEN IDENTIFIED BY IHEALTH LABS, INC. AS THE CUSTOMER HAS THROWN AWAY THE BOX. THE CUSTOMER HAS ONLY COMPARED IT TO OTHER OTC TEST KITS BIAXNOW AND GENOBIO. THE CUSTOMER HAS NO PLANS TO TAKE A PCR TO VERIFY HIS DIAGNOSIS.

    Description of Event or Problem · 0

    CUSTOMER CALLED ON 10/08/2023 TO REPORT RECEIVING A FALSE NEGATIVE REPORT. "HELLO. MY NAME IS (B)(6). MY PHONE NUMBER IS (B)(6), AND YOU MAY CONTACT ME BY TEXTING. AND I ORDERED A PACK OF 5 COVID TESTS THROUGH AMAZON, AND THEY DID NOT WORK. IT WOULDN'T LET ME LIKE PROCESS A REFUND OR A REPLACEMENT THROUGH THE AMAZON APP. IT DIRECTED ME TO THIS PHONE NUMBER AND SAID, TO CALL YOU GUYS I I'M JUST WONDERING IF I CAN GET EITHER A REFUND OR A REPLACEMENT JUST TO SEE IF THEY'LL PICK IT UP THIS TIME, 'CAUSE WHAT HAPPENED IS. I WAS TESTING POSITIVE ON OTHER BRANDS, BUT NEGATIVE ON EYE HEALTH. AND NOW I'M STILL TESTING POSITIVE ON OTHER BRANDS. BUT I'M OUT OF EYE HEALTH, AND I JUST FEEL LIKE I DIDN'T GET THE RIGHT RESULT. SO IF YOU COULD CONTACT ME, THAT WOULD BE WONDERFUL. THANK YOU. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055148 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female