BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

    MDR report key: 19802718 · Received July 22, 2024

    Report

    Report Number
    0002024674-2024-00294
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 22, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QMN
    UDI-DI
    30014613339229
    PMA / PMN Number
    EUA202751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE REPORTED ISSUE FOR THIS LOT. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING HAVING A PATIENT THAT HAS TESTED FLU B FALSE POSITIVE MULTIPLE TIMES. CUSTOMER DOES NOT HAVE AN EXACT TIME FRAME OF TESTING OR NUMBER OF TESTS FOR THE PATIENT. CUSTOMER STATES PCR IS NEGATIVE. TWO REPORTS WILL BE FILED TO REPRESENT UNKNOWN NUMBER OF TESTS. REPORT 2 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004987 SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB QMN QUIDELORTHO CORPORATION 30014613339229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown