BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT XPRESS COV-2/FLU/RSV PLUS

    MDR report key: 23720161 · Received December 4, 2025

    Report

    Report Number
    3004530258-2025-00040
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 16, 2025
    Report Date
    December 4, 2025
    Manufacturer
    CEPHEID
    Product Code
    QOF
    UDI-DI
    07332940008604
    PMA / PMN Number
    K242071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD 2 NASOPHARYNGEAL (NP) SWABS COLLECTED AND PLACED IN 3ML UTM ON (B)(6) 2025. ON THE SAME DAY, ONE SWAB WAS TESTED ON XPERT XPRESS COV-2/FLU/RSV PLUS, LOT 68119, AND RESULTED AS SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, AND RSV NEGATIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. DUE TO THE XPERT RESULT GIVING NEGATIVE ON ALL ANALYTES AND CLINICIAN SUSPECTED PATIENT HAD FLU, THE OTHER NP SWAB WAS TESTED THE SAME DAY ON QUIDEL'S SOFIA FLUA/FLUB RAPID ANTIGEN TEST WHICH RESULTED AS FLU A NEGATIVE, FLU B POSITIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. DATA FOR XPERT XPRESS COV-2/FLU/RSV PLUS SHOWS NO INDICATION OF MALFUNCTION WITH FLU B CT OF 0, INDICATING THERE'S NO TARGET. INTERNAL DATA SHOWS NO ISSUES WITH THE LOT OR ANY COMPLAINT TRENDS WITH THIS LOT. THE CUSTOMER STATED WITH OTHER XPERT LOTS, FLU B IS BEING DETECTED, WHICH STATES FLU B IS CIRCULATING. CEPHEID ADVISED AT THE POSSIBILITY OF THE SOFIA TEST GIVING INACCURATE RESULTS, BUT CUSTOMER DOESN'T HAVE A CASE OPENED WITH QUIDEL. PATIENT IS A 1.5-YEAR-OLD WITH NO UNDERLYING CONDITIONS AND PRESENTED AT THE CLINIC WITH A COUGH AND FLU-LIKE SYMPTOMS. AFTER THE RESULTS FROM XPERT AND (B)(6). THE PATIENT WAS GIVEN THE DIAGNOSIS FOR HAVING FLU, BUT NO TREATMENT WAS PROVIDED. ADVISED PARENTS TO MONITOR PATIENT UNTIL RECOVERY. CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM OR IMPACT DUE TO THE DIFFERING RESULTS. CUSTOMER NO LONGER HAS THE NP SWABS AS THEY ARE DISCARDED AFTER TESTING, HENCE NO OTHER CONFIRMATORY TESTING CAN BE PERFORMED. DETERMINATION OF THE CASE IS INCONCLUSIVE AS WELL AS THE ROOT CAUSE.

    Description of Event or Problem · 0

    US CUSTOMER CONTACTED CEPHEID TO REPORT A QUESTIONABLE NEGATIVE RESULT FOR FLU B USING THE XPERT XPRESS COV-2/FLU/RSV PLUS ASSAY. PATIENT WAS TESTED USING XPERT XPRESS COV-2/FLU/RSV PLUS LOT 68119 WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE. SAMPLE WAS PROCESSED PER IFU. THIS RESULT WAS REPORTED TO THE PHYSICIAN. TWO NASOPHARYNGEAL SWABS WERE COLLECTED FOR THIS PATIENT AT THE SAME TIME. WHEN RESULTS OF XPERT XPRESS COV-2/FLU/RSV PLUS IVD WERE REPORTED AS NEGATIVE FOR ALL TARGETS, THE CUSTOMER QUESTIONED THE FLU RESULTS SINCE THEY HIGHLY SUSPECTED THE PATIENT HAD THE FLU AS THE PATIENT PRESENTED WITH A COUGH AND FLU-LIKE SYMPTOMS. THEY USED THE SECOND SWAB TO TEST WITH THEIR SOFIA QUIDEL RAPID FLU A/FLU B TEST. SAMPLES WERE STORED AT ROOM TEMPERATURE PRIOR TO TESTING. SOFIA QUIDEL RAPID FLU A/FLU B TEST RESULTED IN FLU A NEGATIVE, FLU B POSITIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE LOT NUMBER FOR SOFIA QUIDEL IS UNKNOWN. THERE WERE NO KNOWN UNDERLYING CONDITIONS AND NO KNOWN IMPACT ON THE PATIENT DUE TO THE DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447962 XPERT XPRESS COV-2/FLU/RSV PLUS XPERT XPRESS COV-2/FLU/RSV PLUS QOF CEPHEID 1001491980 07332940008604

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Unknown