BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 20938475 · Received December 12, 2024

    Report

    Report Number
    MW5163594
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    October 3, 2024
    Report Date
    December 11, 2024
    Manufacturer
    CVS HEALTH, QUIDEL CORPORATION/QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN TAKING THE CVS HEALTH BRAND COVID-19 RAPID TEST MANUFACTURED BY THE QUIDEL CORPORATION WE REPEATEDLY OBSERVED A FALSE POSITIVE RESULT DETECTING COVID-19 IN MYSELF AND MY GIRLFRIEND. WE CONCLUDED THE RESULTS WERE FALSE POSITIVES AFTER COMPARING THE RESULTS TO TESTS FROM DIFFERENT MANUFACTURERS. THIS OCCURRED WHEN WE TRAVELLED TO (B)(6), WHERE WE HAD BROUGHT SOME TESTS WITH US ON OUR FLIGHT IN CASE WE FELT WE WERE EXPOSED OR SYMPTOMATIC. WE WERE CONCERNED WE HAD A SYMPTOM OF COVID-19 (GIRLFRIEND HAD SORE THROAT) AND MY TRAVEL GROUP TOOK TESTS WHICH ALL REVEALED A FADED LINE. BUT A FEW DAYS LATER WE DID NOT EXPERIENCE ANY PROGRESSION IN SYMPTOMS AND ALSO TOOK TESTS FROM DIFFERENT MANUFACTURERS/BRANDS THAT INDICATED WE DID NOT HAVE COVID-19. WE USED SIX TESTS IN TOTAL FROM THE SAME BRAND/MANUFACTURER. REFERENCE REPORT: MW5163593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425321 CVS HEALTH AT HOME COVID-19 TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP CVS HEALTH, QUIDEL CORPORATION/QUIDEL CORP. 3766344

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other BIRTH CONTROL.