BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 23378936 · Received October 24, 2025

    Report

    Report Number
    2243471-2025-04332
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    August 7, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    UDI-DI
    00875197005448
    PMA / PMN Number
    P150044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE DISCREPANT RESULT FOR SAMPLE 1 IS THAT THE SAMPLE IS NEAR THE LIMIT OF DETECTION FOR L858R. OVERALL, THE LATE CRITICAL THRESHOLD (CT) VALUES GENERATED IN ALL THE ALLEGED SAMPLES INDICATE THAT THE MUTATION LEVELS ARE LOW. THE CT VALUES GENERATED FOR THE NO MUTATION DETECTED RESULTS ARE OUTSIDE THE THRESHOLD OF DETECTABILITY FOR THE COBAS EGFR ASSAY. ACCORDING TO THE METHOD SHEET, THE DETECTION OF A MUTATION IS DEPENDENT ON THE NUMBER OF COPIES PRESENT IN THE SPECIMEN AND MAY BE AFFECTED BY SAMPLE INTEGRITY, AMOUNT OF ISOLATED DNA, AND THE PRESENCE OF INTERFERING SUBSTANCES. A "NO MUTATION DETECTED" RESULT DOES NOT PRECLUDE THE PRESENCE OF A MUTATION IN THE TARGETED EGFR REGIONS BECAUSE RESULTS DEPEND ON PERCENT MUTANT SEQUENCES, ADEQUATE SAMPLE INTEGRITY, ABSENCE OF INHIBITORS, AND SUFFICIENT DNA TO BE DETECTED. AT THIS TIME, THE PRODUCT IS WORKING AS INTENDED. THE LOCAL TEST MAY HAVE DIFFERENT TECHNOLOGIES AND THEREFORE HAVE DIFFERENT DETECTABILITY THRESHOLDS FOR EACH MUTATION. THE INVESTIGATION DETERMINED THAT THE PRODUCT IS WORKING AS INTENDED, AND THE ALLEGATION IS SAMPLE-SPECIFIC.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY WITH FOUR PATIENT SAMPLES TESTED ON A COBAS Z480 ANALYZER. SAMPLE 1: ON (B)(6) 2025: THE INITIAL RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS REPEATED ON ANOTHER METHOD (OPEN QPCR INSTRUMENT USING TEST-GEN KITS (LOCALLY PRODUCED KIT)) AND THE RESULT WAS POSITIVE FOR THE L858R MUTATION. THE SAMPLE WAS SENT FOR RETESTING TO ANOTHER LABORATORY (METHOD UNKNOWN), WHERE THE MUTATION WAS CONFIRMED. SAMPLE 2: ON (B)(6) 2025: THE INITIAL RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND L858R MUTATION WAS DETECTED. SAMPLE 3: ON (B)(6) 2025: THE INITIAL RESULT WAS L858R MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND L858R AND T790M MUTATIONS WERE DETECTED. SAMPLE 4: ON (B)(6) 2025: THE INITIAL RESULT WAS EXON 19 DEL MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND EXON 19 DEL AND T790M MUTATIONS WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447110 COBAS® EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M25692 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown