BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 12921796 · Received December 2, 2021

    Report

    Report Number
    2243471-2021-03814
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 2, 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
    JA
    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 WERE 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 IN (B)(6) ALLEGED THE GENERATION OF A FALSE EXON20 INSERTION MUTATION RESULT FOR A PATIENT TESTED WITH THE COBAS® EGFR MUTATION TEST V2. UPON REPEAT TESTING WITH OTHER PLATFORMS (ONCOMINE AND AMOY), NO EXON20 INSERTION MUTATION WAS DETECTED. THE PATIENT TRIED TO ENTER A TKI CLINICAL TRIAL SINCE THE COBAS EGFR TEST GENERATED AN EXON20 INSERTION MUTATION DETECTED RESULT. HOWEVER, THE TEST RESULTS USING ONCOMINE AND AMOY WERE NEGATIVE FOR EX20INS, SO THE PATIENT DID NOT ENTER THE TRIAL. NO HARM OR INJURY WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819031 COBAS® EGFR MUTATION TEST V2 SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA 00875197005448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown