BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE SARS ANTIGEN TEST

    MDR report key: 21345940 · Received February 10, 2025

    Report

    Report Number
    0002024674-2025-00124
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    November 20, 2024
    Report Date
    February 10, 2025
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    30014613339373
    PMA / PMN Number
    EUA203086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE DHR FOUND THAT THE LOT MET ALL RELEASE CRITERIA. TESTED 5X RETURNED DEVICES WITH NEGATIVE STANDARD. ALL DEVICES YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE 10 MINUTE RESULT READ TIME. ROOT CAUSE: COULD NOT DUPLICATE WITH RETURNS. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS 2 EVENTS OF BLOOD ON SWAB AFTER SAMPLE COLLECTION. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514225 QUICKVUE SARS ANTIGEN TEST QUICKVUE SARS ANTIGEN TEST QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 709758 30014613339373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown