BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

    MDR report key: 20509232 · Received October 22, 2024

    Report

    Report Number
    0002024674-2024-00534
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 9, 2024
    Report Date
    October 22, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QMN
    PMA / PMN Number
    EUA202751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE CUSTOMER'S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS PATIENT'S NOSE WAS SWABBED WITH NEGATIVE QC SWAB FROM KIT. NO FLUSHING OR ACTION TAKEN. NO REACTION FROM THE CUSTOMER, DID NOT EXPERIENCE BURNING OR IRRITATION. CUSTOMER WAS ADVISED TO MONITOR THE PATIENT AND CONTACT THEIR HEALTH CARE PROVIDER IF ANY ADVERSE REACTIONS OCCUR. QC SWAB PRODUCT INFORMATION WAS PROVIDED FROM THE PRODUCT INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565829 SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB QMN QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 709697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown