BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2 DOD

    MDR report key: 13546982 · Received February 17, 2022

    Report

    Report Number
    3004530258-2022-00015
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 16, 2022
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA203137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 DOD TESTED ON THE GENEXPERT INSTRUMENT. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF TESTING AND HAD BEEN EXPOSED TO POSITIVE INDIVIDUALS. SAMPLE 1 WAS COLLECTED FROM THE PATIENT ON (B)(6) 2022 AND TESTED USING XPERT XPRESS SARS-COV-2 DOD WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO MEDICAL TEAM). SAMPLE 1 WAS RETESTED USING ROCHE COBAS LIAT ON (B)(6) 2022 WHICH RESULTED IN SARS-COV-2 POSITIVE. SAMPLE 1 WAS RETESTED AGAIN ON (B)(6) 2022 USING XPERT XPRESS SARS-COV-2/FLU/RSV WHICH RESULTED IN SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO MEDICAL TEAM). REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED PATIENT HARM. REVIEW OF DATA FROM THE FIRST TEST SHOWED NORMAL SAMPLE PROCESSING CONTROLS (SPC) AND NO DETECTION OF THE SARS TARGETS. AMPLIFICATION AND ENDPOINT FLUORESCENCE (EPF) OF SPC IS WITHIN NORMAL RANGE. REVIEW OF DATA FROM THE SECOND REPEAT RUN SHOWS DETECTION OF SARS-COV-2 WITH A LATE CYCLE THRESHOLD (CT) VALUE AND NORMAL SPC. AMPLIFICATION AND EPF OF TARGET AND SPC WERE NORMAL. THERE WAS NO EVIDENCE OF PRODUCT MALFUNCTION. THE LIKELY ROOT CAUSE IS SAMPLE AT OR BELOW THE ASSAY'S LIMIT OF DETECTION. THERE WAS NO REPORTED PATIENT HARM. AS PER SECTION 3 OF THE XPERT XPRESS SARS-COV-2 EUA IFU; "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 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 EPIDEMIOLOGICAL INFORMATION." 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 DOD TESTED ON THE GENEXPERT INSTRUMENT. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF TESTING AND HAD BEEN EXPOSED TO POSITIVE INDIVIDUALS. SAMPLE 1 WAS COLLECTED FROM THE PATIENT ON (B)(6) 2022 AND TESTED USING XPERT XPRESS SARS-COV-2 DOD WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO MEDICAL TEAM). SAMPLE 1 WAS RETESTED USING ROCHE COBAS LIAT ON (B)(6) 2022 WHICH RESULTED IN SARS-COV-2 POSITIVE. SAMPLE 1 WAS RETESTED AGAIN ON (B)(6)2022 USING XPERT XPRESS SARS-COV-2/FLU/RSV WHICH RESULTED IN SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO MEDICAL TEAM). 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
    997919 CEPHEID XPERT XPRESS SARS-COV-2 DOD COVID-19 RT-PCR TEST QJR CEPHEID 1000288933

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown