BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13510449 · Received February 10, 2022

    Report

    Report Number
    3004530258-2022-00009
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    January 14, 2022
    Report Date
    February 8, 2022
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS. ON (B)(6) 2022, A SAMPLE WAS COLLECTED FROM THE PATIENT INTO THOMAS SCIENTIFIC FLOCKED NASAL SWAB. THE SAMPLE WAS RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST, WHICH RESULTED IN SARS-COV-2 NEGATIVE; FLU A NEGATIVE; FLU B NEGATIVE; RSV NEGATIVE. THIS WAS REPORTED TO THE PHYSICIAN. ON (B)(6) 2021, A SAMPLE WAS COLLECTED FROM THE PATIENT INTO THOMAS SCIENTIFIC FLOCKED NASAL SWAB. THE CUSTOMER RAPIDLY INVERTED 5X, THEN UTILIZED THE SUPPLIED TRANSFER PIPETTE TO TRANSFER CONTENTS INTO CARTRIDGE. THE SAMPLE WAS RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST, WHICH RESULTED IN SARS-COV-2 NEGATIVE; FLU A NEGATIVE; FLU B NEGATIVE; RSV NEGATIVE. THIS WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER RAN THE SAME SECOND SPECIMEN THAT WAS RAN ON THE XPERT XPRESS ON A BIOFIRE RESPITORY PANEL WHERE SARS-COV-2 AND HUMAN RHINOVIRUS/ENTEROVIRUS WERE DETECTED. THIS WAS REPORTED ON (B)(6) 2022. THE PATIENT IS SYMPTOMATIC AND THERE IS NO KNOWN DEATH OR DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. THE PATIENT'S PREVIOUS RESULTS INCLUDED BEING COVID-19 POSITIVE (B)(6) 2020 ON BIOFIRE AND COVID-19 NEGATIVE (B)(6) 2021 ON QUEST. THIS CASE INVOLVES A SYMPTOMATIC PATIENT WHO PRESENTED FOR CARE. THE FIRST SWAB COLLECTED AND RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST WAS NEGATIVE. A SECOND SWAB WAS COLLECTED AND WAS ALSO RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST, WHICH WAS ALSO NEGATIVE. THE SECOND SWAB WAS THEN TESTED BY THE BIOFIRE RESPIRATORY PANEL AND WAS POSITIVE FOR SARSCOV2 AND RHINOVIRUS. THE PCR DATA SHOWED NORMAL AMPLIFICATION OF THE INTERNAL CONTROL INDICATING NO INHIBITION OR INTERFERENCE. THE SARSCOV2 CHANNELS SHOWED NO EVIDENCE OF AMPLIFICATION. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION OR INTERFERENCE. ACCORDING TO THE CUSTOMER, THERE WAS NO IMPACT TO THE PATIENT. FALSE NEGATIVE: AS PER SECTION 3 OF THE XPERT XPRESS SARS-COV-2/FLU/RSV EUA IFU; "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2, INFLUENZA A VIRUS, INFLUENZA B VIRUS AND/OR RSV INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND/OR EPIDEMIOLOGICAL INFORMATION. " 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 PATIENT RESULTS. ON (B)(6) 2022, A SAMPLE WAS COLLECTED FROM THE PATIENT INTO THOMAS SCIENTIFIC FLOCKED NASAL SWAB. THE SAMPLE WAS RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST, WHICH RESULTED IN SARS-COV-2 NEGATIVE; FLU A NEGATIVE; FLU B NEGATIVE; RSV NEGATIVE. THIS WAS REPORTED TO THE PHYSICIAN. ON (B)(6) 2021, A SAMPLE WAS COLLECTED FROM THE PATIENT INTO THOMAS SCIENTIFIC FLOCKED NASAL SWAB. THE CUSTOMER RAPIDLY INVERTED 5X, THEN UTILIZED THE SUPPLIED TRANSFER PIPETTE TO TRANSFER CONTENTS INTO CARTRIDGE. THE SAMPLE WAS RUN ON THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST, WHICH RESULTED IN SARS-COV-2 NEGATIVE; FLU A NEGATIVE; FLU B NEGATIVE; RSV NEGATIVE. THIS WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER RAN THE SAME SECOND SPECIMEN THAT WAS RAN ON THE XPERT XPRESS ON A BIOFIRE RESPITORY PANEL WHERE SARS-COV-2 AND HUMAN RHINOVIRUS/ENTEROVIRUS WERE DETECTED. THIS WAS REPORTED ON (B)(6) 2022. THE PATIENT IS SYMPTOMATIC AND THERE IS NO KNOWN DEATH OR DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. THE PATIENT'S PREVIOUS RESULTS INCLUDED BEING COVID-19 POSITIVE (B)(6) 2020 ON BIOFIRE AND COVID-19 NEGATIVE (B)(6) 2021 ON QUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111953 CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV COVID-19 RT-PCR TEST QJR CEPHEID 1000315999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown