BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 20256942 · Received September 19, 2024

    Report

    Report Number
    2243471-2024-02707
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    UDI-DI
    00875197005448
    PMA / PMN Number
    P150047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS Z 480 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION. THE OBSERVED DISCREPANCY WAS CONSISTENT WITH THE VARIANCES BETWEEN THE SAMPLE TYPES AND THE PLASMA SAMPLES BEING WELL BELOW THE LIMIT OF DETECTION.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE CUSTOMER REPORTED TWO ADDITIONAL SAMPLES WITH QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2. PATIENT 3 TESTED ON (B)(6) 2024, INITIAL RESULT WAS MUTATION NOT DETECTED. A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS S768I MUTATION DETECTED AND THE DNA CONCENTRATION WAS 15NG/UL. PATIENT 4 TESTED ON (B)(6) 2024, INITIAL RESULT WAS MUTATION NOT DETECTED. A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS EXON19DEL MUTATION DETECTED AND THE DNA CONCENTRATION WAS 4NG/UL. FOR THESE TWO ADDITIONAL SAMPLES, THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION. THE DATA SHOWED NO AMPLIFICATION WAS DETECTED FOR BOTH S768I AND EXON19DEL TARGETS, WHICH MAY INDICATE AN INSUFFICIENT AMOUNT OF TARGET DNA FOR DETECTION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2. PATIENT 1 ON (B)(6) 2024, THE INITIAL RESULT WAS MUTATION NOT DETECTED. ON (B)(6) 2024, THE SAME PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. ON (B)(6) 2024, A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. PATIENT 2 ON (B)(6) 2024, THE INITIAL RESULT WAS MUTATION NOT DETECTED. ON (B)(6) 2024, THE SAME PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. ON AN UNKNOWN DATE, A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS EXON19 DEL MUTATION DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431076 COBAS® EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K15109 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown