BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS EGFR MUTATION TEST

    MDR report key: 3843074 · Received January 29, 2014

    Report

    Report Number
    2243471-2014-00002
    Date Received
    January 29, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 30, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    OWD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. NOTE: PRODUCT CODE NQF WAS SELECTED AS THE CLOSEST AVAILABLE CODE. NQF IS IMMUNOHISTOCHEMISTRY ASSAY EGFR. THE PRODUCT IN THIS MDR IS A NUCLEIC ACID TEST (NAT) FOR EGFR. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN TAIWAN FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS EGFR MUTATION TEST, BATCH S06809. THE CUSTOMER TESTED TWO SAMPLES ON (B)(6) 2013 AND THEY BOTH DETECTED EXON 20 INSERTIONS. THEY RERAN THESE TWO SAMPLES AND THE REPEATED RESULTS DID NOT DETECT EXON 20 INSERTIONS. THIS MDR IS BEING FILED FOR SAMPLE 2. MDR 2243471-2014-00001 IS FILED FOR SAMPLE 1. THE ASSOCIATED US PRODUCT IS M/N 06471463190 P120019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63668 COBAS EGFR MUTATION TEST EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION/ MRNA EXPRESSION IVD, NAT OWD ROCHE MOLECULAR SYSTEMS, INC. S06809

    Patients

    Seq Age Sex Outcome Treatment
    1