BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12958086 · Received December 7, 2021

    Report

    Report Number
    3004530258-2021-00440
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 7, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 FROM THE PATIENT ON (B)(6) 2021, WHICH WAS TESTED ON XPERT SARS-COV-2 AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 2 WAS COLLECTED FROM PATIENT ON (B)(6) 2021, WHICH TESTED ON XPERT-SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 RETEST 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). TESTING WAS PERFORMED ON PATIENT WITHOUT SUSPICION OF COVID-19 WHICH IS OUTSIDE THE INTENDED USE. REVIEW OF THE DATA PROVIDED DETERMINED THIS TO BE A TRUE POSITIVEWITH NORMAL SAMPLE PROCESSING CONTROL (SPC) AMPLIFICATION AND ENDPOINT FLUORESCENCE (EPF). THE LIKELY ROOT CAUSE IS TARGET NEAR LIMIT OF DETECTION OR NEAR CUT-OFF. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND NO REPORT OF 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 SECTION H3 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 SAMPLE 1 FROM THE PATIENT ON (B)(6) 2021, WHICH WAS TESTED ON XPERT SARS-COV-2 AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 2 WAS COLLECTED FROM PATIENT ON (B)(6) 2021, WHICH TESTED ON XPERT-SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 RETEST 1 OCCURRED ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED IN SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). 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
    1855264 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000259966

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown