BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV

    MDR report key: 12809500 · Received November 15, 2021

    Report

    Report Number
    3004530258-2021-00421
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 12, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT-1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV AND RESULTED AS SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-2 OCCURRED ON (B)(6)2021 AND TESTED ON BIOFIRE, WHICH RESULTED IN RSV DETECTED (UNKNOWN IF REPORTED TO THE PHYSICIAN). 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. AS PER SECTION 3 OF XPERT XPRESS SARS-COV-2/FLU/RSV, 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. NOTE FOR SECTION DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS SARS-COV-2/FLU/RSV 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/FLU/RSV. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT-1 ON (B)(6) 2021, WHICH WAS TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV AND RESULTED AS SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-2 OCCURRED ON (B)(6) 2021 AND TESTED ON BIOFIRE, WHICH RESULTED IN RSV DETECTED (UNKNOWN IF REPORTED TO THE PHYSICIAN). 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
    1713602 CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV COVID-19 RT-PCR TEST QJR CEPHEID 1000286985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown