BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20131814 · Received September 3, 2024

    Report

    Report Number
    0002024674-2024-00434
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 4, 2024
    Report Date
    September 3, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: .A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: ONLINE REVIEW.

    Description of Event or Problem · 0

    CUSTOMER REPORTING WHAT THEY FEEL ARE TWO FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES BOTH THEMSELVES AND THEIR SPOUSE WERE SYMPTOMATIC WITH COVID LIKE SYMPTOMS BUT TESTED NEGATIVE USING THIS TEST. NO CONFLICTING OR CONFIRMATION TESTING WAS PERFORMED THE CUSTOMER JUST FEELS THEY HAVE COVID. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874962 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDELORTHO CORPORATION 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown