BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12492926 · Received September 17, 2021

    Report

    Report Number
    0002024674-2021-00046
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 17, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    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 REPORTING INSERTING THE SWAB IN THE REAGENT FIRST AND THEN COLLECTING THE SPECIMEN FROM THE ANTERIOR NARE FOR QV SARS OTC --TSS ADVISED TO FLUSH THE NOSE IMMEDIATELY AND SEEK CARE IF NECESSARY SWAB IMMERSED IN THE REAGENT FIRST AND THEN COLLECTED THE SPECIMEN.

    Additional Manufacturer Narrative · 1

    SUBJECT: CONSUMER REPORTING INSERTING THE SWAB IN THE REAGENT FIRST AND THEN COLLECTING THE SPECIMEN FROM THE ANTERIOR NARE FOR QV SARS OTC --TSS ADVISED TO FLUSH THE NOSE IMMEDIATELY AND SEEK CARE IF NECESSARY. INVESTIGATION CONCLUSION: A REVIEW OF THE PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE CUSTOMER'S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. 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. 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 REPORTING INSERTING THE SWAB IN THE REAGENT FIRST AND THEN COLLECTING THE SPECIMEN FROM THE ANTERIOR NARE FOR QV SARS OTC --TSS ADVISED TO FLUSH THE NOSE IMMEDIATELY AND SEEK CARE IF NECESSARY. SWAB IMMERSED IN THE REAGENT FIRST AND THEN COLLECTED THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386598 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1