BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV

    MDR report key: 12652798 · Received October 18, 2021

    Report

    Report Number
    3004530258-2021-00414
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 16, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    "US CUSTOMER CONTACTED CEPHEID TO DISCUSS A PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE AND REPORTED TO THE PHYSICIAN. SAMPLE 1 REPEAT 1 OCCURRED (B)(6) 2021 ON HOLOGIC PANTHER PLATFORM AND RESULTED AS SARS-COV-2 POSITIVE. RESULTS REPORTED TO THE PHYSICIAN. SAMPLE 1 REPEAT 2 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE. RESULTS NOT REPORTED TO THE PHYSICIAN. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND NO REPORT OF PATIENT HARM. AS PER SECTION 3 OF XPERT XPRESS SARS-COV-2/FLU/RSV, EUA IFU; "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. NOTE DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID."

    Description of Event or Problem · 0

    "US CUSTOMER CONTACTED CEPHEID TO DISCUSS A PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE AND REPORTED TO THE PHYSICIAN. SAMPLE 1 REPEAT 1 OCCURRED (B)(6) 2021 ON HOLOGIC PANTHER PLATFORM AND RESULTED AS SARS-COV-2 POSITIVE. RESULTS REPORTED TO THE PHYSICIAN. SAMPLE 1 REPEAT 2 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE. RESULTS NOT REPORTED TO THE PHYSICIAN. REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546129 CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV COVID-19 RT-PCR TEST QJR CEPHEID 1000285446

    Patients

    Seq Age Sex Outcome Treatment
    1