BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2 P150044

    MDR report key: 24888204 · Received April 15, 2026

    Report

    Report Number
    2243471-2026-01434
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    UDI-DI
    00875197005448
    PMA / PMN Number
    P150044
    Removal / Correction Number
    Z-0083-2022 RES88607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® EGFR MUTATION TEST V2 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON THE COBAS Z 480 ANALYZER. THE INITIAL RESULT WAS EXON20 INSERTION MUTATION DETECTED. THE REPEAT RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS TESTED USING THE NEXT GENERATION SEQUENCING (NGS) AND THE RESULT WAS NEGATIVE FOR EXON20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103548 COBAS® EGFR MUTATION TEST V2 P150044 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG ASKU 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1