BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12809496 · Received November 15, 2021

    Report

    Report Number
    3004530258-2021-00426
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 12, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT-1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 PRESUMPTIVE POSITIVE (NOT REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS-COV-2, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). ADDITIONALLY, CUSTOMER STATED ALSO TESTED THE SAMPLE AND GOT A NEGATIVE RESULT. HOWEVER, THIS TEST DATA WAS UNABLE TO BE IDENTIFIED DUE TO CLOAKING. REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO KNOWN HARM TO PATIENTS. THE ROOT CAUSE WAS DETERMINED TO BE TARGET/S NEAR LIMIT OF DETECTION OR NEAR CUT-OFF. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED 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. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT-1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 PRESUMPTIVE POSITIVE (NOT REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS-COV-2, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). ADDITIONALLY, CUSTOMER STATED ALSO TESTED THE SAMPLE AND GOT A NEGATIVE RESULT. HOWEVER, THIS TEST DATA WAS UNABLE TO BE IDENTIFIED DUE TO CLOAKING. REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO KNOWN HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713463 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000291509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown