BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12356964 · Received August 23, 2021

    Report

    Report Number
    0002024674-2021-00039
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 15, 2021
    Report Date
    August 23, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP.

    Description of Event or Problem · 0

    CONSUMER DIPPED NASAL SWAB INTO REAGENT BEFORE INSERTING IN NASAL CAVITY - CONSUMER REPORTS THEY HAD A BLOODY NOSE AS A RESULT - TS DOCUMENTING AND RECOMMENDED CONSUMER FOLLOW-UP WITH PROVIDER IF SYMPTOMS PERSIST.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS. THE INSTRUCTIONS ARE PRECISE AND CLEAR ON HOW THE TEST SHOULD BE PERFORMED. IT IS INCUMBENT UPON THE USER TO FOLLOW THE INSTRUCTIONS AS THEY ARE CALLED OUT IN THE PACKAGE INSERT. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE PERFORMED A REVIEW OF THE PACKAGE INSERT (PI) 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. ADDITIONALLY, WE REVIEWED THE COMPLAINT HISTORY LOG FOR THIS LOT AND NO SIGNIFICANT TREND WAS IDENTIFIED. THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR.

    Description of Event or Problem · 1

    CONSUMER DIPPED NASAL SWAB INTO REAGENT BEFORE INSERTING IN NASAL CAVITY - CONSUMER REPORTS THEY HAD A BLOODY NOSE AS A RESULT - TS DOCUMENTING AND RECOMMENDED CONSUMER FOLLOW-UP WITH PROVIDER IF SYMPTOMS PERSIST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253736 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402

    Patients

    Seq Age Sex Outcome Treatment
    1