BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12389547 · Received August 30, 2021

    Report

    Report Number
    3004530258-2021-00234
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    October 26, 2020
    Report Date
    August 27, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SAMPLES FROM A PATIENT WITH NO SYMPTOMS OF COVID-19. SAMPLE-1 WAS COLLECTED AND TESTED (B)(6) 2020 USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE-2 WAS COLLECTED AND TESTED (B)(6) 2020 USING BD MAX, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). CEPHEID PATIENT SAFETY BOARD DEEMED TESTING ON PATIENT THAT IS NOT SUSPECTED OF COVID-19 TO BE OFF-LABEL. REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NORMAL AMPLIFICATION CURVES. ROOT CAUSE IS DUE TO TARGET NEAR LOD. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED PATIENT HARM. FALSE POSITIVE RESULTS FOR SARS-COV-2 COULD LEAD TO INCORRECT MANAGEMENT OF SYMPTOMATIC PATIENTS, INCLUDING UNNECESSARY ISOLATION OR QUARANTINE, MISALLOCATION OF RESOURCES, DELAYED DIAGNOSIS AND TREATMENT FOR OTHER INFECTIONS OR HEALTH CONDITIONS, OR UNNECESSARY ANTIVIRAL TREATMENT. CEPHEID'S PATIENT SAFETY BOARD CONSULT CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO ASSOCIATED PATIENT HARM OR CHANGE TO PATIENT TREATMENT. RESULTS ARE FOR THE IDENTIFICATION OF SARS-COV-2 RNA. AS PER SECTION 3 OF XPERT XPRESS SARS-COV-2 EUA IFU; POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. 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 SAMPLES FROM A PATIENT WITH NO SYMPTOMS OF COVID-19. SAMPLE-1 WAS COLLECTED AND TESTED (B)(6) 2020 USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE-2 WAS COLLECTED AND TESTED (B)(6) 2020 USING BD MAX, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO 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
    1286564 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000221761

    Patients

    Seq Age Sex Outcome Treatment
    1