BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12292168 · Received August 8, 2021

    Report

    Report Number
    3004530258-2021-00052
    Event Type
    Malfunction
    Date Received
    August 8, 2021
    Date of Event
    May 21, 2021
    Report Date
    August 6, 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. ON (B)(6) 2021 CUSTOMER TESTED UNKNOWN SAMPLE TYPE ON XPERT XPRESS SARS-COV-2, LOT 04209, PRODUCING A RESULT OF SARS-COV-2 POSITIVE. THEN, ADDITIONAL SAMPLE COLLECTED AND SENT TO THE REGIONAL LAB TESTED ON ROCHE TEST PRODUCING A RESULT OF SARS-COV-2 NEGATIVE (DATES UNKNOWN). THE RESULT OF SARS-COV-2 POSITIVE WAS REPORTED TO THE PHYSICIAN. CEPHEID'S PATIENT SAFETY BOARD REVIEWED THE DATA PROVIDED BY THE CUSTOMER. REVIEW OF THE INITIAL POSITIVE RESULTS SHOWS N2 TARGET DETECTION ONLY WITH A WEAK/LATE CYCLE THRESHOLD VALUE. N2 AND SPC AMPLIFICATION AND END POINT FLUORESCENCE APPEARS NORMAL. NO EVIDENCE OF PRODUCT MALFUNCTION. THIS LIKELY REPRESENTS VIRAL NUCLEIC ACID AT OR BELOW THE ASSAY'S LIMIT OF DETECTION IN COMBINATION WITH DIFFERENCES IN TEST METHODS BETWEEN XPERT XPRESS SARS-COV-2 AND ROCHE ASSAY. NO PATIENT HARM OCCURRED AS A RESULT. 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. 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. 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. ON (B)(6) 2021 CUSTOMER TESTED UNKNOWN SAMPLE TYPE ON XPERT XPRESS SARS-COV-2, LOT 04209, PRODUCING A RESULT OF SARS-COV-2 POSITIVE. THEN, ADDITIONAL SAMPLE COLLECTED AND SENT TO THE REGIONAL LAB TESTED ON ROCHE TEST PRODUCING A RESULT OF SARS-COV-2 NEGATIVE (DATES UNKNOWN). THE RESULT OF SARS-COV-2 POSITIVE WAS REPORTED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189277 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000257059

    Patients

    Seq Age Sex Outcome Treatment
    1