BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 16350869 · Received February 10, 2023

    Report

    Report Number
    0002024674-2023-00020
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 10, 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

    H10: CORRECTION TO MANUFACTURER NARRATIVE: INVESTIGATION CONCLUSION: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS. ROOT CAUSE: NO PROBLEM FOUND. SOURCE: PHONE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS. QC INVESTIGATION #2022-01 DETERMINED THAT THE REPORTED PINK SHADING ON THE STRIP IS A NATURAL PHENOMENON AND IT IS NOT RELATED TO ANY MANUFACTURING DEFECT. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE REVIEWED THE COMPLAINT HISTORY LOG FOR THIS LOT AND NO ADVERSE TREND WAS IDENTIFIED. QC INVESTIGATION #2022-01 DETERMINED THAT THE REPORTED PINK SHADING ON THE STRIP IS A NATURAL PHENOMENON AND IT IS NOT RELATED TO ANY MANUFACTURING DEFECT. THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS. ROOT CAUSE: NO PROBLEM FOUND. SOURCE: PHONE (925) 337-2982.

    Description of Event or Problem · 0

    QV SARS OTC, X1 PINK LINE NEAR ARROWS-TSS PROVIDED GUIDANCE. CUSTOMER REPORTED A SMALL AMOUNT OF BLOOD ON THE NASAL SWAB AFTER SWABBING THEIR RIGHT NOSTRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54488 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