BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20072848 · Received August 26, 2024

    Report

    Report Number
    0002024674-2024-00374
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 26, 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: WEBSITE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING CONSISTENTLY TESTING POSITIVE ON THIS TEST BUT NEGATIVE ON OTHER BRAND OF RAPID ANTIGEN TEST. CUSTOMER IS NOT SURE HOW MANY POSITIVE TESTS THEY HAD. TWO REPORTS WILL BE FILED FOR UNKNOWN NUMBER OF POSITIVE RESULTS. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28318 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDELORTHO CORPORATION F42276 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown