BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 14042828 · Received April 7, 2022

    Report

    Report Number
    2243471-2022-00369
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 7, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    UDI-DI
    00875197005448
    PMA / PMN Number
    P150047
    Removal / Correction Number
    2243471-08-24-2021-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROCHE RECEIVED COMPLAINTS FROM CUSTOMERS REPORTING THE GENERATION OF FALSE MUTATION DETECTED RESULTS FOR THE EXON 20 INSERTION (EX20INS) MUTATION WHEN USING THE COBAS® EGFR MUTATION TEST V2. DURING IN-HOUSE TESTING USING CUSTOMER-PROVIDED FFPET SAMPLES, AN EX20INS FALSE MUTATION DETECTED RESULT WAS REPRODUCED FOR ONE OUT OF 8 FFPET SAMPLES, WHICH WAS PROCESSED FOLLOWING THE VALIDATED SAMPLE PREPARATION METHOD FROM THE INSTRUCTIONS FOR USE. ALTHOUGH THE MAJORITY OF CASES REPORTED WERE FROM USERS USING FFPET SAMPLES, THE GENERATION OF FALSE MUTATION DETECTED EX20INS RESULTS WITH PLASMA SPECIMENS WAS REPORTED IN ONE CASE. A FALSE MUTATION DETECTED EX20INS RESULT COULD LEAD TO HARM UNDER SPECIFIC SCENARIOS. CONSIGNEES WILL BE NOTIFIED OF THE ISSUE WITH INSTRUCTION TO FOLLOW THE INSTRUCTIONS FOR USE FOR SAMPLE INPUT REQUIREMENTS. ADDITIONALLY, IF AN EX20INS MUTATION DETECTED RESULT IS GENERATED WITH THE COBAS® EGFR MUTATION TEST V2, CUSTOMERS MUST CONFIRM THE RESULT WITH ANOTHER METHOD (E.G., SEQUENCING OR OTHER PCR-BASED TESTS). THE MOST LIKELY CAUSE OF THE DISCREPANCY OBSERVED IS DUE TO FALSE POSITIVE DETECTION OF EX20INS. ANOTHER POSSIBILITY IS THAT THE SAMPLE CONTAINS LOW LEVELS OF MUTATION NEAR THE CUT-OFF OF THE ASSAY. SAMPLES NEAR THE LOD OF THE ASSAY ARE EXPECTED TO WAVER BETWEEN POSITIVE AND NEGATIVE RESULTS WITH REPEAT TESTING. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER FROM GREECE ALLEGED POTENTIAL FALSE-POSITIVE RESULT FOR EXON 20 INSERTION (EX20INS) WITH COBAS® EGFR MUTATION TEST V2. THE TISSUE SAMPLE WAS INITIALLY TESTED WITH COBAS® EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE CUSTOMER CONDUCTED A CONFIRMATORY TEST USING NEXT GENERATION SEQUENCING (NGS). EXON20INS MUTATION WAS NOT DETECTED WITH THIS CONFIRMATORY TEST. THE NO EXON20INS MUTATION DETECTED RESULT WAS REPORTED OUT. NO HARM OR SERIOUS INJURY WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912573 COBAS® EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H08593 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown