BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12242292 · Received July 28, 2021

    Report

    Report Number
    3004530258-2021-00005
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    September 19, 2020
    Report Date
    July 26, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED A SAMPLE FROM A PATIENT WHO HAD PRESENTED TI THE EMERGENCY DEPARTMENT WITH SMOKE INHALATION FOLLOWING A HOUSE FIRE. PATIENT SAMPLES WERE RUN ON TWO TESTS. THE FIRST TEST OCCURRED ON (B)(6) 2020 USING A NP SWAB ON ABBOTT ID NOW ANALYZER THAT PRODUCED A RESULT OF COVID-19 POSITIVE. THE SECOND TEST OCCURRED ON (B)(6) 2020 USING AN NP SWAB ON XPERT XPRESS SARS-COV-2 THAT PRODUCED A RESULT OF SARS-COV-2 NEGATIVE. IT IS UNKNOWN IF THESE RESULTS WERE REPORTED TO THE PHYSICIAN. CEPHEID'S PATIENT SAFETY BOARD CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO ASSOCIATED PATIENT HARM OR CHANGE TO PATIENT TREATMENT. REVIEW OF CUSTOMER PROVIDED DATA SHOWED NORMAL SPC AMPLIFICATION, INDICATING NO INTERFERENCE FROM SOOT MATERIAL, AND NO EVIDENCE OF PRODUCT MALFUNCTION. PATIENT EXPIRED DUE TO SMOKE INHALATION INJURY. CUSTOMER DID NOT SUSPECT COVID-19 IN THIS PATIENT. CEPHEID'S PATIENT SAFETY BOARD REVIEW DETERMINED THIS TO BE A TRUE NEGATIVE WITH NORMAL SAMPLE PROCESSING CONTROL (SPC) AMPLIFICATION. 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 CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO ASSOCIATED PATIENT HARM OR CHANGE TO PATIENT TREATMENT AS AN OUTCOME OF THE TEST RESULTS. 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. 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 · 1

    THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED A SAMPLE FROM A PATIENT WHO HAD PRESENTED TI THE EMERGENCY DEPARTMENT WITH SMOKE INHALATION FOLLOWING A HOUSE FIRE. PATIENT SAMPLES WERE RUN ON TWO TESTS. THE FIRST TEST OCCURRED ON (B)(6) 2020 USING A NP SWAB ON ABBOTT ID NOW ANALYZER THAT PRODUCED A RESULT OF COVID-19 POSITIVE. THE SECOND TEST OCCURRED ON (B)(6) 2020 USING AN NP SWAB ON XPERT XPRESS SARS-COV-2 THAT PRODUCED A RESULT OF SARS-COV-2 NEGATIVE. IT IS UNKNOWN IF THESE RESULTS WERE REPORTED TO THE PHYSICIAN. CEPHEID'S PATIENT SAFETY BOARD CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO ASSOCIATED PATIENT HARM OR CHANGE TO PATIENT TREATMENT. REVIEW OF CUSTOMER PROVIDED DATA SHOWED NORMAL SPC AMPLIFICATION, INDICATING NO INTERFERENCE FROM SOOT MATERIAL, AND NO EVIDENCE OF PRODUCT MALFUNCTION. PATIENT EXPIRED DUE TO SMOKE INHALATION INJURY. CUSTOMER DID NOT SUSPECT COVID-19 IN THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133752 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000243539

    Patients

    Seq Age Sex Outcome Treatment
    1