BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2 P150044

    MDR report key: 21706518 · Received March 27, 2025

    Report

    Report Number
    2243471-2025-00896
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 23, 2025
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FINDINGS CONCLUDED NO PRODUCT ISSUE WAS IDENTIFIED. THE LIKELY ROOT CAUSE OF THE DISCREPANCIES IS THE CUSTOMER WORKFLOW DUE TO OFF-LABEL QUANTIFICATION METHOD AND DIFFERENCES IN TECHNOLOGY.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY UNKNOWN NUMBER OF PATIENT SAMPLES TESTED ON COBAS Z480 ANALYZER. ON (B)(6) 2025 (PLASMA SAMPLE) RESULT WAS "NO MUTATION DETECTED". ON (B)(6) 2025 (TISSUE SAMPLE) RESULT WAS "NO MUTATION DETECTED". ON AN UNKNOWN DATE, A SEQUENCING (NGS) TEST WAS PERFORMED AND THE RESULT WAS DEL19 AND L858R DETECTED. ON AN UNKNOWN DATE, ANOTHER NON-ROCHE PCR TEST WAS PERFORMED AND THE RESULT WAS DEL19 AND L858R DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659231 COBAS® EGFR MUTATION TEST V2 P150044 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K19029 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown