BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 19610943 · Received June 25, 2024

    Report

    Report Number
    0002024674-2024-00301
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    April 5, 2024
    Report Date
    June 25, 2024
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: WEB.

    Description of Event or Problem · 0

    CONSUMER SWABBED NOSE AND WHEN REMOVING SWAB FROM FIRST NOSTRIL IT WAS COMPLETELY RED. THIS NOSTRIL HAD BEEN A BIT BLOODY ON AND OFF DURING CONGESTION. THE TEST SHOWED NEGATIVE. NO BLOOD PRESENT PRIOR TO THE TEST BEING PERFORMED. CUSTOMER STATES THAT THEY SWABBED ABOUT ½ TO ¾ OF AN INCH INTO EACH NOSTRIL. THE NEXT DAY A DOCTOR DID RAPID FLU/COVID TEST. NO BLOOD. ALL NEGATIVE. TECHNICAL SUPPORT ASSESSMENT/TROUBLESHOOTING: IT IS RECOMMENDED TO SWAB ABOUT ½ TO ¾ OF AN INCH INTO EACH NOSTRIL. OUR INTERNAL TEAM DETERMINED THAT 15% OF HUMAN BLOOD DID NOT SHOW AN INTERFERENCE WITH THE TEST. IF YOU HAD A LARGER AMOUNT OF BLOOD, WE RECOMMEND RETESTING USING A NEW SWAB AND NEW TEST. TECHNICAL SERVICES ADVISED TO FOLLOW UP WITH YOUR HEALTHCARE PROVIDER FOR FURTHER GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596762 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CARDIOVASCULAR INC. 20402 F42020 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown