BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

    MDR report key: 19785371 · Received July 19, 2024

    Report

    Report Number
    0002024674-2024-00290
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 19, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QMN
    UDI-DI
    30014613339229
    PMA / PMN Number
    EUA202751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PATIENT THAT TESTED FALSE POSITIVE FOR BOTH SARS AND FLU B. CONFIRMATION TESTING WAS PERFORMED FOR SARS AND CAME BACK NEGATIVE. CONFIRMATION TESTING WAS DONE FOR FLU AND CAME BACK POSITIVE BUT CUSTOMER DOES NOT FEEL THE CUSTOMER HAS FLU. REPORT 2 OF 2 (FLU B).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032600 SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB QMN QUIDELORTHO CORPORATION 709330 30014613339229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown