BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20666068 · Received November 12, 2024

    Report

    Report Number
    0002024674-2024-00537
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 12, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: NO ADVERSE TREND WAS IDENTIFIED FOR THIS LOT NUMBER FOR THE REPORTED ISSUE. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS A LITTLE BLOOD PRESENT ON SWAB AFTER SAMPLE COLLECTION. PATIENT IS PRESCRIBED BLOOD-THINNER MEDICATION. NO APPARENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974752 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 000279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown