BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS EGFR MUTATION TEST

    MDR report key: 4419759 · Received January 14, 2015

    Report

    Report Number
    2243471-2015-00003
    Date Received
    January 14, 2015
    Date of Event
    December 10, 2014
    Report Date
    February 13, 2015
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    OWD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER: 13-FEB-2015. FOLLOW UP REPORT 1. ADDITIONAL INFORMATION/DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER YES. (B)(4). A CUSTOMER IN (B)(6) ALLEGED FALSE MUTATION NOT DETECTED G719X RESULTS FOR FFPET SAMPLES WHILE PERFORMING A VALIDATION STUDY WITH THE COBAS EGFR MUTATION TEST; A COMPETITOR ASSAY (ENTROGEN) GENERATED MUTATION DETECTED RESULTS FOR G719X. THE FFPET SAMPLES WERE RETURNED AND SUBJECTED TO SEQUENCING, WHICH REVEALED WILD-TYPE MUTATIONS FOR EGFR. AS SEQUENCING DID NOT DETECT ANY G719X MUTATIONS, THE MUTATION NOT DETECTED RESULTS GENERATED FOR THE SAMPLES WITH THE COBAS EGFR MUTATION TEST AT THE CUSTOMER SITE ARE EXPECTED. INVESTIGATIVE TESTING WAS PERFORMED ON THE RETAIN KIT T05841 AND MET SPECIFICATIONS. BASED ON THE RESULTS OF SEQUENCING ANALYSIS AND RETAIN TESTING, NO PRODUCT MALFUNCTION WAS IDENTIFIED AND THE TEST PERFORMED AS INTENDED WITH THE PARTICULAR FFPET SAMPLES. (B)(4)

    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. COBAS EGFR MUTATION TEST IVD UDI (B)(4). THE ASSOCIATED US PRODUCT SHARES THE SAME IDENTIFICATION ABOVE. PMA P120019. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT A SAMPLE WAS IDENTIFIED AS WILD TYPE (MUTATION NOT DETECTED) BUT WAS EXPECTED TO BE A G719X MUTANT WHEN USING THE COBAS EGFR MUTATION TEST, LOT T05841. THE SAMPLE WAS AN FFPE PANEL SAMPLE. WHEN THE SAMPLE AND SLIDES WERE SENT BACK TO THE SAMPLE PROVIDER, THE PROVIDER CONFIRMED THE G719X MUTATION USING THE ENTROGEN ASSAY. A NEW EXTRACTION WAS PERFORMED AND RUN WITH THE COBAS EGFR MUTATION TEST AT THE CUSTOMER SITE AND AGAIN GENERATED A MUTATION NOT DETECTED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32607 COBAS EGFR MUTATION TEST EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION / MRNA EXPRESSION IVD, NAT OWD ROCHE MOLECULAR SYSTEMS T05841

    Patients

    Seq Age Sex Outcome Treatment
    1