BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12368824 · Received August 25, 2021

    Report

    Report Number
    3004530258-2021-00206
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    December 1, 2020
    Report Date
    August 25, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE FROM A PATIENT WITH UNKNOWN STATUS REGARDING SYMPTOMS OF COVID-19. SAMPLE-1 WAS COLLECTED AND TESTED (B)(6) 2020 USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). CUSTOMER REPORTED THAT SAMPLE-2 WAS COLLECTED FROM PATIENT AT ANOTHER FACILITY ON UNKNOWN DATE AND TESTED USING UNKNOWN METHOD, RESULTING IN SARS-COV-2 POSITIVE. NO DATA IS PROVIDED FOR THIS TEST. CUSTOMER PROVIDED ONLY TEST REPORT DATA WITH NO AMPLIFICATION CURVE GRAPH. ROOT CAUSE IS DUE TO SAMPLE VARIABILITY/QUALITY. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO PATIENT HARM. AS PER SECTION 3 OF XPERT XPRESS SARS-COV-2 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 TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID."

    Description of Event or Problem · 0

    THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE FROM A PATIENT WITH UNKNOWN STATUS REGARDING SYMPTOMS OF COVID-19. SAMPLE-1 WAS COLLECTED AND TESTED (B)(6) 2020 USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). CUSTOMER REPORTED THAT SAMPLE-2 WAS COLLECTED FROM PATIENT AT ANOTHER FACILITY ON UNKNOWN DATE AND TESTED USING UNKNOWN METHOD, RESULTING IN SARS-COV-2 POSITIVE. NO DATA IS PROVIDED FOR THIS TEST. REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265280 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000215040

    Patients

    Seq Age Sex Outcome Treatment
    1