BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12285790 · Received August 6, 2021

    Report

    Report Number
    3004530258-2021-00059
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    June 21, 2021
    Report Date
    August 4, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    "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 NON-SYMPTOMATIC PATIENT ON (B)(6) 2021. THE SAMPLE WAS TESTED ON XPERT XPRESS SARS-COV-2, REAGENT LOT 05101 PRODUCING THE RESULT OF SARS-COV-2 POSITIVE. A RETEST WAS PERFORMED ON THE SAME DAY, THE SAME PATIENT SAMPLE WAS RETESTED ON XPERT XPRESS SARS-COV-2, REAGENT LOT 04724 PRODUCING THE RESULT OF SARS-COV-2 NEGATIVE. THE RESULTS WERE REPORTED TO THE PHYSICIAN. CEPHEID PATIENT SAFETY BOARD MEMBER REVIEWED THE DATA PROVIDED BY THE CUSTOMER. UNKNOWN IF OFF-LABEL USE OCCURRED SINCE THERE WAS NO INFORMATION ON SAMPLE TYPE AND COLLECTION MEDIA. TESTING WAS PERFORMED ON ASYMPTOMATIC PATIENT BUT UNKNOWN IF THERE WAS SUSPICION OF COVID-19. REVIEW OF THE INITIAL POSITIVE SHOWS A SINGLE N2 TARGET DETECTION WITH LATE CYCLE THRESHOLD VALUE. TARGET AND SPC AMPLIFICATION AND EPF APPEAR NORMAL. REVIEW OF THE REPEAT RESULT SHOWS NORMAL SPC AMPLIFICATION AND EPF. NO EVIDENCE OF PRODUCT MALFUNCTION. THIS LIKELY REPRESENTS A SAMPLE CONTAINING CONCENTRATION OF VIRAL NUCLEIC ACID AT OR BELOW THE ASSAY'S LIMIT OF DETECTION, WHICH IS COMMONLY SEEN IN ASYMPTOMATIC PATIENTS WITH PREVIOUS INFECTION THAT SPORADICALLY SHED RESIDUAL VIRAL RNA. NO PATIENT HARM OCCURRED AS A RESULT. 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. 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

    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 NON-SYMPTOMATIC PATIENT ON (B)(6) 2021. THE SAMPLE WAS TESTED ON XPERT XPRESS SARS-COV-2, REAGENT LOT 05101 PRODUCING THE RESULT OF SARS-COV-2 POSITIVE. A RETEST WAS PERFORMED ON THE SAME DAY, THE SAME PATIENT SAMPLE WAS RETESTED ON XPERT XPRESS SARS-COV-2, REAGENT LOT 04724 PRODUCING THE RESULT OF SARS-COV-2 NEGATIVE. THE RESULTS WERE REPORTED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182873 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000267791

    Patients

    Seq Age Sex Outcome Treatment
    1