BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20001006 · Received August 20, 2024

    Report

    Report Number
    0002024674-2024-00305
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 16, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    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 PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE REPORTED PROBLEM WE BELIEVE IS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR SOURCE: PHONE.

    Description of Event or Problem · 0

    CONSUMER SWABBED NOSE AFTER PLACING IT IN LIQUID REAGENT SOLUTION: TECHNICAL SERVICE SPECIALIST PROVIDED GUIDANCE. CONSUMER SWABBED NOSE AFTER PLACING SWAB IN LIQUID REAGENT FIRST. SAID THE LIQUID WAS ALL UP HIS NOSE. REPORTS FREQUENT SNEEZING AFTER. TEST WAS NEGATIVE. TEST WAS REPEATED AGAIN AND WAS NEGATIVE. TECHNICAL SERVICES TROUBLESHOOTING: TSS ADVISED PLEASE REFER TO THE HAZARDOUS INGREDIENTS FOR LIQUID REAGENT SECTION IN THE USER INSTRUCTIONS. IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH PLENTY OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ADVICE. HTTPS://WWW.POISON.ORG/CONTACT-US OR 1-800-222-1222, CUSTOMER UNDERSTOOD SAID HE WILL CALL 1-800-222-1222.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210179 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDELORTHO CORPORATION 20402 2311003 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown