BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12517091 · Received September 22, 2021

    Report

    Report Number
    3004530258-2021-00396
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 22, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 HAD 5 PATIENT RESULTS THAT WERE QUESTIONED. 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 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 1 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 1 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 2 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 2 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 3 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 3 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 3 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 4 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 4 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 4 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 5 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 5 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 5 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). THERE WAS NOT ENOUGH DATA TO DETERMINE ROOT CAUSE. ROOT CAUSE IS INCONCLUSIVE. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED 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. 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 HAD 5 PATIENT RESULTS THAT WERE QUESTIONED. 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 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 1 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 1 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 2 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 2 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 3 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 3 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 3 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 4 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 4 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 4 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 5 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2 AND RESULTED AS SARS-COV-2 POSITIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 5 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 5 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (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
    1408752 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000226533

    Patients

    Seq Age Sex Outcome Treatment
    1