BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS

    MDR report key: 13102518 · Received December 28, 2021

    Report

    Report Number
    3004530258-2021-00442
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 28, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA210505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COV-2/FLU/RSV PLUS TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 FROM THE PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED ON THE SAME DAY ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED ON THE SAME DAY ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS RETESTED ON (B)(6) 2021 ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO THE PHYSICIAN). REVIEW OF DATA PROVIDED BY THE CUSTOMER FOR THE INITIAL NEGATIVE TEST RESULTS SHOWED WEAK AMPLIFICATION. REPEAT TESTING WITH POSITIVE RESULTS SHOWED LATE CYCLE THRESHOLD VALUES. THE CUSTOMER SUSPECTED INSUFFICIENT SPECIMEN MIXING AS THE CAUSE FOR INITIAL NEGATIVE RESULTS. EXAMINATION OF PCR RAW DATA SHOWED NO EVIDENCE OF INHIBITION OR PRODUCT MALFUNCTION. ACCORDING TO THE CUSTOMER THERE WAS NO HARM TO PATIENTS AS A RESULT OF DISCREPANT RESULTS. AS PER XPERT XPRESS SARS-COV-2S 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 COV-2/FLU/RSV PLUS TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 FROM THE PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED ON THE SAME DAY ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED ON THE SAME DAY ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS RETESTED ON (B)(6) 2021 ON XPERT XPRESS COV-2/FLU/RSV PLUS AND RESULTED IN SARS-COV-2 POSITIVE (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
    1998185 CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS COVID-19 RT-PCR TEST QJR CEPHEID 1000325764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown