BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 21140603 · Received January 13, 2025

    Report

    Report Number
    0002024674-2025-00044
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 13, 2025
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    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: THE PROVIDED LOT NUMBER WAS NOT ASSOCIATED WITH THE REPORTED PRODUCT. THEREFORE, WE PERFORMED A SEARCH FOR SIMILAR COMPLAINTS OF THE REPORTED PROBLEM. A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS BLOOD ON SWAB AFTER SAMPLE COLLECTION. NOTED DRY NOSE PRIOR TO SAMPLE COLLECTION. NO APPARENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460805 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown