BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12292085 · Received August 7, 2021

    Report

    Report Number
    3004530258-2021-00050
    Event Type
    Malfunction
    Date Received
    August 7, 2021
    Date of Event
    May 28, 2021
    Report Date
    August 6, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLES FROM 4 PATIENTS; 1 HAD SYMPTOMS OF COVID-19 AND IT IS UNKNOWN IF THE OTHER 3 WERE SYMPTOMATIC FOR COVID-19. PATIENT-1'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, NOT REPORTED TO PHYSICIAN). PATIENT WAS SYMPTOMATIC AT TIME OF TESTING. PATIENT-1-RETEST-1 WAS RUN ON (B)(6) 2021 USING APTIMA SARS-COV-2, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-2'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, NOT REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-2-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-3'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, NOT REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-3-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-4'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, UNKNOWN IF REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-4-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). ROOT CAUSE OF PATIENT-1 AND PATIENT-4 DISCREPANCIES DUE TO TARGET NEAR LOD AND ROOT CAUSE OF PATIENT-2 AND PATIENT-3 DISCREPANCIES DUE TO MUTATION OR GENETIC DRIFT. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO 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 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

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLES FROM 4 PATIENTS; 1 HAD SYMPTOMS OF COVID-19 AND IT IS UNKNOWN IF THE OTHER 3 WERE SYMPTOMATIC FOR COVID-19. PATIENT-1'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, NOT REPORTED TO PHYSICIAN). PATIENT WAS SYMPTOMATIC AT TIME OF TESTING. PATIENT-1-RETEST-1 WAS RUN ON (B)(6) 2021 USING APTIMA SARS-COV-2, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-2'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, NOT REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-2-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-3'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (NOT REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-3-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, RESULTING IN SARS-COV-2 NEGATIVE (REPORTED TO PHYSICIAN). PATIENT-4'S SAMPLE WAS COLLECTED (B)(6) 2021 AND TESTED SAME DAY USING XPERT XPRESS SARS-COV-2, RESULTING IN SARS-COV-2 PRESUMPTIVE POSITIVE (E+, N2-, UNKNOWN IF REPORTED TO PHYSICIAN). IT IS UNKNOWN IF PATIENT WAS SYMPTOMATIC. PATIENT-4-RETEST-1 WAS RUN ON UNKNOWN-DATE USING THE PERKINELMER CHEMAGIC 360 FOR NUCLEIC ACID EXTRACTION FOLLOWED BY THE APPLIED BIOSYSTEMS QUANTSTUDIO 7 FOR PCR, 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 PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189216 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000255895

    Patients

    Seq Age Sex Outcome Treatment
    1