BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS EGFR MUTATION TEST V2

    MDR report key: 12173581 · Received July 15, 2021

    Report

    Report Number
    2243471-2021-02501
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    May 12, 2021
    Report Date
    September 16, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    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). UPDATED TO REFLECT DATA PROVIDED AND SAMPLES IDENTIFIED. UPDATED PATIENT CODES. CHANGED DEVICE CODES FROM NON REPRODUCIBLE RESULTS TO FALSE POSITIVE (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER FROM (B)(6) ALLEGED 22 SAMPLES GENERATED DISCREPANT RESULTS FOR EX20INS WHEN TESTED WITH THE COBAS EGFR MUTATION TEST V2, LOTS G18263 AND G25391. TWENTY (20) SAMPLES GENERATED EX20INS MUTATION DETECTED RESULTS IN THE INITIAL TESTS. RETESTS GENERATED NO-MUTATION-DETECTED RESULTS. TWO ADDITIONAL SAMPLES GENERATED EX20INS MUTATION DETECTED RESULTS IN THE ORIGINAL AND REPEAT TESTING. SEQUENCING ANALYSIS (AMOYDX) GENERATED NEGATIVE RESULTS. ONLY DATA FOR 4 OF THE ALLEGED SAMPLES WERE PROVIDED. NO HARM WAS ALLEGED. AN INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068485 COBAS EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G18263 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1