BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13102513 · Received December 28, 2021

    Report

    Report Number
    3004530258-2021-00441
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 30, 2021
    Report Date
    January 12, 2022
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED FOR THE REPORTED PRODUCT'S EXPIRATION DATE IN SECTION D4 AND MANUFACTURE DATE IN SECTION H4.

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 1 ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS COLLECTED ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 3 WAS COLLECTED ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 3 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). NO PCR REPORTS OR TEST REPORTS WERE PROVIDED BY THE CUSTOMER TO ASSESS RUN DATA. THE LOCAL CEPHEID TEAM HAD REVIEWED RUN DATA AND REPLACED THE INSTRUMENT. CARRYOVER CONTAMINATION COULD NOT BE RULED OUT. THE LIKELY ROOT CAUSE IS INCONCLUSIVE. 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 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/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 1 ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS COLLECTED ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 3 WAS COLLECTED ON AN UNKNOWN DATE, WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED IN SARS-COV-2 POSITIVE (REPORTED TO PHYSICIAN). SAMPLE 1 FROM PATIENT 1 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 2 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 FROM PATIENT 3 WAS RETESTED BY ABBOTT ID NOW ON AN UNKNOWN DATE, WHICH RESULTED IN SARS-COV-2 NEGATIVE (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
    1997579 CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV COVID-19 RT-PCR TEST QJR CEPHEID 1000294985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown