BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 23156737 · Received September 26, 2025

    Report

    Report Number
    0002024674-2025-00556
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 26, 2025
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    PMA / PMN Number
    EUA210269/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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 CUSTOMER'S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. SOURCE: EMAIL.

    Description of Event or Problem · 0

    CONSUMER REPORTS THEY INSERTED THE SWAB INTO THE REAGENT SOLUTION BEFORE SWABBING NOSE. NO APPARENT ADVERSE EVENT. CUSTOMER UNRESPONSIVE TO REQUESTS FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279240 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown