BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 19767873 · Received July 17, 2024

    Report

    Report Number
    0002024674-2024-00285
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE DHR FOUND THAT THE LOT MET ALL RELEASE CRITERIA. A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE REPORTED ISSUE FOR THIS LOT. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING 6 FALSE POSITIVE SARS RESULTS RECEIVED DURING EMPLOYEE TESTING (SOME HAD MILD SYMPTOMS WHILE OTHERS WERE ASYMPTOMATIC). CUSTOMER STATES THE RESULTS WERE CONFIRMED NEGATIVE BY PCR. REPORT 3 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148444 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDELORTHO CORPORATION F42275 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown