BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

    MDR report key: 19831771 · Received July 25, 2024

    Report

    Report Number
    0002024674-2024-00297
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QMN
    UDI-DI
    30014613339229
    PMA / PMN Number
    EUA202751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF THE DHR FOUND THAT THE LOT MET ALL RELEASE CRITERIA. A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE REPORTED ISSUE FOR THIS LOT. ROOT CAUSE: UNABLE TO DETERMINE SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING A CONFLICTING SARS RESULT ON ONE PATIENT. CUSTOMER STATES THE PATIENT INITIALLY TESTED NEGATIVE FOR BOTH FLU AND SARS, THEN WHEN THE SAME CASSETTE WAS READ ON A DIFFERENT INSTRUMENT WAS POSITIVE FOR SARS. THEY THEN RE-RAN THE PATIENT SWAB ON THE SARS ONLY ASSAY AND RECEIVED A SARS POSITIVE RESULT. NO FURTHER CONFIRMATION TESTING HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200370 SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB QMN QUIDELORTHO CORPORATION 709078 30014613339229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown