BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12585070 · Received October 6, 2021

    Report

    Report Number
    3004530258-2021-00404
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 3, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    UDI-DI
    07332940007890
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS 16 PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. TESTING OF ASYMPTOMATIC PATIENTS WAS FOR TRAVEL SCREENING PURPOSES. THIS IS OFF LABEL USE. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS-COV-2 POSITIVE (RESULTS WERE REPORTED). PATIENT 1 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV AND RESULTED AS SARS COV-2 NEGATIVE/FLU A NEG/ FLU B NEG/ RSV NEG (RESULTS WERE REPORTED). THE FOLLOWING PATIENTS HAVE RESULTS QUESTIONED BUT NO REPEAT OR OTHER TESTS WERE PERFORMED. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 3 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 4 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 5 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED)). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 6 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 7 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 8 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 9 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 10 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE(RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 11 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 12 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 13 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 14 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 15 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 16 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). ROOT CAUSE IS CONTAMINATION AND/OR CARRYOVER. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND NO REPORT OF 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. NOTE FOR SECTION DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF EITHER XPERT XPRESS SARS-COV-2 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 16 PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. TESTING OF ASYMPTOMATIC PATIENTS WAS FOR TRAVEL SCREENING PURPOSES. THIS IS OFF LABEL USE. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS-COV-2 POSITIVE (RESULTS WERE REPORTED). PATIENT 1 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV AND RESULTED AS SARS COV-2 NEGATIVE/FLU A NEG/ FLU B NEG/ RSV NEG (RESULTS WERE REPORTED). THE FOLLOWING PATIENTS HAVE RESULTS QUESTIONED BUT NO REPEAT OR OTHER TESTS WERE PERFORMED. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 3 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 4 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 5 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED)). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 6 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 7 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 8 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 9 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 10 ON (B)(6)2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE(RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 11 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 12 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 13 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 14 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 15 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 16 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2. RESULTS WERE RETURNED AS SARS COV-2 POSITIVE (RESULTS WERE REPORTED). 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
    1480711 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000281813 07332940007890

    Patients

    Seq Age Sex Outcome Treatment
    1