BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS EGFR MUTATION TEST V2

    MDR report key: 12507598 · Received September 21, 2021

    Report

    Report Number
    2243471-2021-03332
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    July 29, 2020
    Report Date
    September 21, 2021
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM THE US ALLEGED DISCREPANT RESULTS WITH THREE PATIENT SAMPLES USING COBAS® EGFR MUTATION KIT (LOT F12858 AND G18263) COMPARED WITH NEXT GENERATION SEQUENCING (NGS) (AMPLISEQ HOTSPOT PANEL V2) ON THE ION PGM. WHEN TESTING WITH COBAS® EGFR, THE SAMPLE GENERATED POSITIVE EXON 20 INSERTION, HOWEVER, NGS DID NOT DETECT THIS MUTATION. FOR SAMPLE 1, INITIAL 3-RUNS WERE PERFORMED WITH DNA EXTRACTED ON (B)(6) 2020 (4-SLIDES, 113.0 NG/L). THE SECOND EXTRACTION OCCURRED ON (B)(6) 2021 (3-SLIDES, 35.3NG/UL), TESTED IN THE 4TH RUN. FOR THE OTHER 2 ALLEGED SAMPLES, NO INFORMATION (RAW DATA, SAMPLE IDS, BATCH NUMBERS, AND SAMPLE CONCENTRATION) WERE PROVIDED TO SUPPORT THE ALLEGATION. PER METHOD SHEET OF COBAS® DNA SAMPLE PREPARATION KIT, THE CUSTOMER SHOULD USE 1 SLIDE USING 5-MICRON THICKNESS. USING MORE SLIDES HAS NOT BEEN VALIDATED WITH COBAS® EGFR MUTATION KIT V2. NO HARM OR INJURY WAS INDICATED. TWO MDRS WILL BE FILED, ONE FOR EACH ALLEGED KIT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407393 COBAS EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA F12858 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1