BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12278591 · Received August 4, 2021

    Report

    Report Number
    3004530258-2021-00047
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    May 28, 2021
    Report Date
    August 4, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    PMA / PMN Number
    EUA200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. (B)(6). NOTE FOR 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

    THIS MDR IS BEING FILED IN ACCORDANCE WITH THE ADDITIONAL REPORTING CONDITIONS INCLUDED IN CEPHEID'S EMERGENCY USE AUTHORIZATION (EUA) FOR THIS ASSAY. IN ADDITION TO THE EXISTING REPORTING REQUIREMENTS UNDER THE MDR REGULATION (21 CFR 803), FDA'S EUA AUTHORIZATION LETTER REQUIRES CEPHEID TO REPORT TO FDA ANY SUSPECTED OCCURRENCE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS AND SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2 TESTED ON THE GENEXPERT INSTRUMENT. (B)(6). REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175055 CEPHEID XPERT XPRESS SARS-COV-2 COVID-19 RT-PCR TEST QJR CEPHEID 1000214434

    Patients

    Seq Age Sex Outcome Treatment
    1