BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 15157924 · Received August 3, 2022

    Report

    Report Number
    0002024674-2022-09163
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 20, 2022
    Report Date
    April 27, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    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. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE REVIEWED MANUFACTURING RECORDS FOR THIS LOT. ALL RELEASE CRITERIA WERE MET. ADDITIONALLY, NO SIGNIFICANT TRENDS WERE IDENTIFIED IN THE COMPLAINT HISTORY LOG. THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE: 305-304-1313.

    Additional Manufacturer Narrative · 0

    UPDATES TO MANUFACTURERS NARRATIVE 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. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    QV SARS OTC REPORTED 2X FALSE POSITIVE -- TSS REVIEWED THE PI. THIS IS ONE OF 2 MDRS SUBMITTED FOR SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868989 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 NONE 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown