BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 21139477 · Received January 13, 2025

    Report

    Report Number
    0002024674-2025-00043
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 13, 2025
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    30014613340188
    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: PHONE.

    Description of Event or Problem · 0

    REPORTS PLACING SWAB INTO LIQUID REAGENT, THEN INTO NOSE FOR SAMPLE COLLECTION. CUSTOMER STATES THEY DID NOT HAVE ANY IRRITATION AND FELT FINE. NO APPARENT ADVERSE EVENT. CUSTOMER DIRECTED TO POISON CONTROL CONTACT INFORMATION IN USER INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517281 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 3767519 30014613340188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown