BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 19666077 · Received July 3, 2024

    Report

    Report Number
    3008573045-2024-00020
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    February 18, 2024
    Report Date
    June 20, 2024
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAD TAKEN A PCR TEST [?]THE RESAULT WAS NEGATIVE.THE CUSTOMER DID NOT PROVIDE A SPECIFIC PCR TESTING TIME; FOLLOWING AN INVESTIGATION BY THE MANUFACTURER QUALITY CONTROL TEAM, WHICH INVOLVED TESTING 50 SAMPLES FROM THE IDENTIFIED LOT 234CO20412, NO FALSE POSITIVES WERE DETECTED.

    Description of Event or Problem · 0

    EVENT DETAILS: I GOT COVID TESTS FROM USPS. I TOOK TWO AND BOTH GAVE FALSE POSITIVE. I HAD TO RUSH TO MED EXPRESS TO FIND OUT I DID NOT HAVE COVID. I WORK IN A MEDICAL FIELD AND I CAN'T TAKE THIS STUFF LIGHTLY. NOW MY BILL IS AROUND $250. I'M NOT PAYING. YOUR COMPANY IS RESPONSIBLE FOR SUCH A FIASCO! LET ME KNOW HOW YOU WANT TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756134 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 234CO20412

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown