BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 18659104 · Received February 6, 2024

    Report

    Report Number
    MW5151103
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 2, 2024
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A CVS COVID-19 AT HOME TEST KIT AT THE (B)(6) LOCATION. I TOOK THE FIRST OF TWO TESTS FROM THIS KIT ON (B)(6) 2024, AND RECEIVED A POSITIVE RESULT. I TOOK A BINAXNOW BRAND RAPID TEST THE SAME DAY AND RECEIVED A NEGATIVE RESULT. ON (B)(6) 2024 I WENT TO A (B)(6) URGENT CARE AND RECEIVED A NEGATIVE RAPID TEST AND A NEGATIVE PCR(POLYMERASE CHAIN REACTION) TEST. I CAME HOME AND TOOK THE SECOND CVS TEST AND IT AGAIN YIELDED A POSITIVE RESULT. UNCLEAR HOW THIS IS POSSIBLE. THIS TESTING KIT HAS YIELDED TWO FALSE POSITIVES. QUIDEL CORPORATION WAS CONTACTED VIA EMAIL AND PHONE REGARDING THIS ISSUE AND I WAS TOLD TO CONTACT THE CVS FOR REIMBURSEMENT. NO ACCOUNTABILITY. CURRENTLY IN PROCESS WITH CVS TO GAIN REIMBURSEMENT FOR THIS FAULTY TEST BUT PEOPLE NEED TO BE MADE AWARE OF QUIDEL PHARMACEUTICALS. REFERENCE REPORT: MW5151104.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907584 CVS HEALTH AT HOME COVID-19 TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION F42150

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention B12| MULTIVITAMIN| VITAMIN C