BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 19812435 · Received July 23, 2024

    Report

    Report Number
    0002024674-2024-00296
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 23, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QKP
    PMA / PMN Number
    EUA210269/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE REPORTED ISSUE FOR THIS LOT. ROOT CAUSE: INSUFFICIENT INFORMATION SOURCE: EMAIL.

    Description of Event or Problem · 0

    CUSTOMER REPORTING WHAT THEY FEEL ARE 2 FALSE NEGATIVE SARS RESULTS FOR THEIR DAUGHTER. CUSTOMER STATES THEIR DAUGHTER WAS SYMPTOMATIC FOR TWO DAYS AND HAD TWO NEGATIVE RESULTS IN ONE DAY. CUSTOMER TOOK DAUGHTER TO URGENT CARE (TIME BETWEEN TESTING AND URGENT CARE UNKNOWN) AND RECEIVED A POSITIVE PCR TEST. REPORT 2 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483807 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDELORTHO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown