BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 14052721 · Received April 8, 2022

    Report

    Report Number
    2243471-2022-00382
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 8, 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
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE, THE CUSTOMER USES 4 SLIDES OF 4 MICRONS EACH. THE METHOD SHEET CALLS TO START WITH ONE 5 MICRON SLIDE. IT WAS ALSO NOTED THAT THE CUSTOMER IS USING OLD BATCH CARDS WHEN TESTING WHICH SHOWS THE BATCHES ARE EXPIRED. THE DNA ISOLATION KIT WAS EXPIRED AT THE TIME OF THE TESTING DONE FOR BOTH THESE SAMPLES. 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 · 0

    A CUSTOMER FROM ECUADOR ALLEGED DISCREPANT RESULTS FOR TWO PATIENTS WHILE USING THE COBAS® EGFR MUTATION TEST V2.0 ASSAY. THE FIRST SAMPLE INITIALLY GENERATED AN EXON 20INS MUTATION DETECTED RESULT. THE SAME SAMPLE WAS RETESTED WITH QPCR FROM IDYLLA BIOCARTIS AND NO MUTATION WAS DETECTED. THE SECOND SAMPLE INITIALLY GENERATED EXON 20INS AND EXON 19DEL MUTATIONS DETECTED RESULTS. NO OTHER INFORMATION WAS PROVIDED FOR THIS SAMPLE. THE RESULTS WERE NOT RELEASED. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187047 COBAS® EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G25391 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown