BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDANT360 CDX

    MDR report key: 16966825 · Received May 19, 2023

    Report

    Report Number
    3012090384-2023-00001
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    January 11, 2023
    Report Date
    May 17, 2023
    Manufacturer
    GUARDANT HEALTH INC.
    Product Code
    PQP
    PMA / PMN Number
    P200010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS IDENTIFIED BY AN INTERNAL QA PROCESS. UPON DISCOVERY, GH INITIATED A BIOINFORMATICS REVIEW WHICH SHOWED RAW DATA WITH UNIQUE FEATURES OF THE SUPPORTING READS COMPATIBLE WITH A FALSE POSITIVE SNV. THIS IS A RARE OCCURENCE, WITH ESTIMATED PREVALENCE OF ~2 IN 10,000 TESTS AND IS WITHIN THE FDA-APPROVED DEVICE PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    DURING A REVIEW OF PATIENT RECORDS FOR QUALITY ASSURANCE PURPOSES, GUARDANT HEALTH, INC. IDENTIFIED A TEST RESULT FOR A PATIENT WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHERE EGFR L858R WAS REPORTED AS POSITIVE, BUT IT WAS A FALSE POSITIVE. A CORRECTED REPORT WAS ISSUED. HOWEVER, THE TREATING DOCTOR BASED THERAPY SELECTION ON THE INITIAL FALSE-POSITIVE RESULT. IT IS UNCLEAR IF THE G360 CDX FALSE POSITIVE TEST RESULT MAY HAVE CAUSED OR CONTRIBUTED HARM TO THE PATIENT OR EVENTUAL DEATH. GUARDANT HEALTH IS REPORTING THIS EVENT TO THE FDA OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644138 GUARDANT360 CDX NEXT GENERATION SEQUENCING ONCOLOGY PANEL, SOMATIC OR GERMLINE PQP GUARDANT HEALTH INC. GUARDANT360 CDX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other