BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS COV-2 PLUS

    MDR report key: 17818294 · Received September 26, 2023

    Report

    Report Number
    3004530258-2023-00016
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 26, 2023
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA220187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B4 DATE OF THIS REPORT HAS BEEN CORRECTED FROM 25-SEP-2023 TO 26-SEP-2023.

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS. ON (B)(6) 2023, A SAMPLE WAS COLLECTED FROM THE PATIENT. THE SAMPLE WAS PROCESSED PER PI ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 POSITIVE. THIS WAS REPORTED TO THE DOCTOR. THE INFECTIOUS DISEASE DOCTOR AT THE SITE WANTED TO SEND THIS SAMPLE OUT FOR VARIANT SEQUENCING DUE TO SUSPICION ABOUT THE CT VALUES, SO A RETEST WAS REQUESTED. ONLY N2 AMPLIFIED WITH CT 43.3 AND ENDPT 37. RETEST 1: THE SAME ORIGINAL SAMPLE WAS RETESTED PER PI ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 POSITIVE. AGAIN, ONLY N2 AMPLIFIED WITH CT 42.1 AND ENDPT 60. RETEST 2: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 NEGATIVE. RETEST 3: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 POSITIVE. RETEST 4: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS SARS COV-2/FLU/RSV PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 NEGATIVE. SOME SARS-COV-2 AMPLIFICATION SEEN AND ENDPT 15. UNKNOWN IF THE NEGATIVE RESULTS WERE REPORTED TO THE DOCTOR. ALL 5 TESTS WERE DONE BY DIFFERENT OPERATORS. SAMPLES ARE REFRIGERATED BETWEEN TESTS. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. PATIENT HAD A PREVIOUS POSITIVE A MONTH AGO. PATIENT WAS BEING TESTED PER A SCREENING PROTOCOL, AND DUE TO THE CONFLICTING RESULTS, THE PROVIDER IS TREATING THE PATIENT AS NEGATIVE, BUT NO CHANGES WERE MADE TO THE PATIENT CHART. REVIEW OF THE INITIAL AND SECOND RUN ON XPRESS COV-2 PLUS SHOWS DETECTION OF N2 TARGET ONLY, WITH WEAK CT VALUE. FOR THE INITIAL RUN, SPC AND N2 AMPLIFICATION CURVE AND EPF APPEAR NORMAL. FOR SECOND RUN, SPC AND N2 EPF APPEARS NORMAL; UNABLE TO ASSESS AMPLIFICATION CURVE. FOR THIRD AND FOURTH RUNS ON XPRESS COV-2 PLUS, SPC APPEARS NORMAL; NOTABLE FOR THE FOURTH RUN HAS ALL TARGETS DETECTED AND WITH LATE CT VALUES. REPEAT ON XPRESS COV-2/FLU/RSV PLUS SHOWS NORMAL SPC AND NO SARS-COV-2 DETECTED, HOWEVER ELEVATED EPF AND WEAK AMPLIFICATION CURVE IS OBSERVED. NO EVIDENCE OF PRODUCT MALFUNCTION. ALSO, NOTED IS THE PATIENT WAS A PREVIOUS POSITIVE PRIOR TO THIS TESTING. LIKELY ROOT CAUSE IS SAMPLE AT OR BELOW THE LOD OF THE TEST. DESPITE MULTIPLE ATTEMPTS TO CONTACT PRIMARY AND SECONDARY CONTACTS, NO RESPONSE RECEIVED. LOST TO FOLLOW UP. UNABLE TO CONFIRM NO REPORTS OF PATIENT HARM. FALSE POSITIVE: 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 THE XPERT XPRESS COV-2 PLUS EUA IFU; "POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF DISEASE." NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS COV-2 PLUS 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 DISCREPANT RESULTS. ON 05-SEP-2023, A SAMPLE WAS COLLECTED FROM THE PATIENT. THE SAMPLE WAS PROCESSED PER PI ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 POSITIVE. THIS WAS REPORTED TO THE DOCTOR. THE INFECTIOUS DISEASE DOCTOR AT THE SITE WANTED TO SEND THIS SAMPLE OUT FOR VARIANT SEQUENCING DUE TO SUSPICION ABOUT THE CT VALUES, SO A RETEST WAS REQUESTED. ONLY N2 AMPLIFIED WITH CT 43.3 AND ENDPT 37. RETEST 1: THE SAME ORIGINAL SAMPLE WAS RETESTED PER PI ON XPERT XPRESS COV-2 PLUS ON 05-SEP-2023. THIS RESULTED IN SARS COV-2 POSITIVE. AGAIN, ONLY N2 AMPLIFIED WITH CT 42.1 AND ENDPT 60. RETEST 2: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 NEGATIVE. RETEST 3: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS COV-2 PLUS ON (B)(6) 2023. THIS RESULTED IN SARS COV-2 POSITIVE. RETEST 4: THE SAMPLE WAS AGAIN RETESTED ON XPERT XPRESS SARS COV-2/FLU/RSV PLUS ON 06-SEP-2023. THIS RESULTED IN SARS COV-2 NEGATIVE. SOME SARS-COV-2 AMPLIFICATION SEEN AND ENDPT 15. UNKNOWN IF THE NEGATIVE RESULTS WERE REPORTED TO THE DOCTOR. ALL 5 TESTS WERE DONE BY DIFFERENT OPERATORS. SAMPLES ARE REFRIGERATED BETWEEN TESTS. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. PATIENT HAD A PREVIOUS POSITIVE A MONTH AGO. PATIENT WAS BEING TESTED PER A SCREENING PROTOCOL, AND DUE TO THE CONFLICTING RESULTS, THE PROVIDER IS TREATING THE PATIENT AS NEGATIVE, BUT NO CHANGES WERE MADE TO THE PATIENT CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096597 CEPHEID XPERT XPRESS COV-2 PLUS COVID-19 RT-PCR TEST QJR CEPHEID 1000519579

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown