BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12356966 · Received August 23, 2021

    Report

    Report Number
    0002024674-2021-00038
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 15, 2021
    Report Date
    August 23, 2021
    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

    CUSTOMER PROCEDURAL ERROR: CUSTOMER REPORTED PLACING THE SWAB IN THE SOLUTION PRIOR TO INSERTING INTO NOSE WITH QV OTC.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. 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

    CUSTOMER PROCEDURAL ERROR: CUSTOMER REPORTED PLACING THE SWAB IN THE SOLUTION PRIOR TO INSERTING INTO NOSE WITH QV OTC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253741 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP 20402 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1