BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2 P150044

    MDR report key: 24753436 · Received April 1, 2026

    Report

    Report Number
    2243471-2026-01198
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 30, 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
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA SHOWS SIGMOIDAL CURVES AND IS CONSISTENT WITH ALL THREE RUNS. NO ABNORMALITIES WERE OBSERVED IN ANY OF THE CONTROLS. OVERALL, THE RESULTS APPEAR TO BE TRUE POSITIVE RESULTS. THE OBSERVED DISCREPANCY MAY BE DUE TO DIFFERENCES IN TECHNOLOGY, SENSITIVITY, AND/OR SPECIFICITY BETWEEN THE ASSAYS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS (B)(4). THE INVESTIGATION IS ONGOING. FULL E1 INITIAL REPORTER ESTABLISHMENT NAME:(B)(6).

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE COBAS® EGFR MUTATION TEST V2 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS Z480 ANALYZER. (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED THE SAMPLE WAS REPEATED ON TWO OTHER METHODS, AMOY AND IDYLLA, AND NO MUTATION WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18727 COBAS® EGFR MUTATION TEST V2 P150044 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M25692 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown