BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12565813 · Received October 1, 2021

    Report

    Report Number
    3004530258-2021-00402
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 1, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS 4 PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. TESTING OF PATIENT WAS USED FOR SCREENING PURPOSES. THIS IS OFF LABEL. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 1 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 1 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 2 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 2 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 3 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 3 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 3 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 4 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 4 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 4 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). ROOT CAUSE IS TARGET NEAR LOD (TARGET/S NEAR LIMIT OF DETECTION OR NEAR CUT-OFF). 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 XPERT XPRESS SARS-COV-2/FLU/RSV 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 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 4 PATIENTS RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. TESTING OF PATIENT WAS USED FOR SCREENING PURPOSES. THIS IS OFF LABEL. CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 1 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 1 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 2 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 2 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 3 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 3 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 3 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM ASYMPTOMATIC PATIENT 4 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV. RESULTS WERE RETURNED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 4 SAMPLE 1 REPEAT 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POS/FLU A NEG/FLU B NEG/RSV NEG (REPORTED TO THE PHYSICIAN). PATIENT 4 SAMPLE 2 WAS COLLECTED ON (B)(6) 2021, WHICH WAS TESTED ON NONACUS VIRPATH SARS-COV-2 MULTIPLEX QRT-PCR AND RESULTED AS COVID-19 NOT DETECTED (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
    1460551 CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV COVID-19 RT-PCR TEST QJR CEPHEID 1000237498

    Patients

    Seq Age Sex Outcome Treatment
    1