BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® EGFR MUTATION TEST V2

    MDR report key: 13091239 · Received December 27, 2021

    Report

    Report Number
    2243471-2021-03930
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    October 14, 2021
    Report Date
    June 14, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    UDI-DI
    00875197005448
    PMA / PMN Number
    P150047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROCHE IDENTIFIED THAT A CUSTOMER OUTSIDE OF THE UNITED STATES WAS USING A NON-COMMERCIAL EGFR TISSUE ASAP VERSION (COBAS® EGFR TISSUE ASAP V1.0.0.1512), WHICH IS A PRE-LAUNCH VERSION THAT WAS NEVER COMMERCIALIZED. THE CUSTOMER SHOULD HAVE BEEN USING THE COMMERCIAL TISSUE ASAP VERSION: COBAS® EGFR TISSUE P1 AP VERSION 1.0.0.1560 (LAUNCHED 2015). IN THE CUSTOMER¿S DATA, (B)(4) SAMPLES WERE IDENTIFIED WITH A "MUTATION DETECTED" RESULT FOR THE EX20INS MUTATION USING THE NON-COMMERCIAL TISSUE ASAP (V1.0.0.1512); IF THE CUSTOMER WAS USING THE COMMERCIALIZED TISSUE ASAP (V1.0.0.1560), THE QUESTIONED RESULTS WOULD HAVE BEEN REPORTED AS "NO MUTATION DETECTED" FOR THE EX20INS MUTATION. NO IMPACT IS EXPECTED FOR OTHER EGFR MUTATIONS REPORTED BY THE COBAS® EGFR MUTATION TEST V2, INCLUDING EX19DEL, G719X, S768I, T790M, AND L861Q. IT IS TO BE NOTED THAT THE EX20INS "MUTATION DETECTED" RESULTS WERE NOT REPORTED OUT; RATHER, THEY WERE REPORTED AS "INDETERMINATE". ALSO, THE CUSTOMER HAD THE COMMERCIALIZED TISSUE ASAP (V1.0.0.1560) INSTALLED ON ITS SYSTEM IN (B)(6) 2022. THE USE OF THE NON-COMMERCIAL TISSUE ASAP IS NOT LIKELY TO CAUSE SERIOUS ADVERSE HEALTH CONSEQUENCES. CUSTOMERS WERE PREVIOUSLY INSTRUCTED IN AUGUST 2021 TO CONFIRM EX20INS "MUTATION DETECTED" RESULTS GENERATED WITH THE COBAS® EGFR MUTATION TEST V2 WITH ANOTHER ORTHOGONAL METHOD (E.G., SEQUENCING OR OTHER PCR-BASED TESTS) BEFORE RELEASING THE FINAL TEST REPORTS. IF THE CONFIRMATORY TESTING IS PERFORMED AS INSTRUCTED AT THE CUSTOMER¿S SITES, THE USE OF COBAS® EGFR MUTATION TEST V2 WITH THE NON-COMMERCIAL TISSUE ASAP VERSION V1.0.0.1512 FOR EX20INS MUTATION DETECTION WILL BE NOT LIKELY TO CAUSE ADVERSE EVENTS IN THE AFFECTED PATIENT POPULATION. CURRENT INFORMATION SUGGESTS THAT THIS SITUATION IS UNIQUE TO A SINGLE OVERSEAS COUNTRY. THE RELEVANT ROCHE AFFILIATE ORGANIZATION WILL BE NOTIFIED TO ENSURE ALL CUSTOMERS IN THAT COUNTRY ARE USING THE COMMERCIAL ASAP AND THAT ANY LOCAL COPIES OF THE NON-COMMERCIAL ASAP ARE QUARANTINED AND LOCALLY DESTROYED, IMMEDIATELY. ADDED INFO IN B6 AND UPDATED DATE OF EVENT TO EARLIEST RUN DATE. ADDED B14 ANALYSIS OF PRODUCTION RECORDS AND B11 HISTORICAL DATA ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED TO SHARE THE CONCLUSIONS. INITIAL REPORTER: (B)(6). (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER FROM (B)(6) ALLEGED A HIGH NUMBER OF EX20INS POSITIVE RESULTS USING TWO LOTS OF THE COBAS EGFR MUTATION TEST V2 SINCE (B)(6) 2021. A REVIEW OF THE DATA IDENTIFIED A TOTAL OF 6 GENERATED EX20INS POSITIVE RESULTS. NO APPARENT HARM OR INJURY WAS INDICATED IN RELATION TO THE EVENT. AN INVESTIGATION IS ONGOING. TWO (2) MDRS WILL BE FILED, ONE FOR EACH OF THE REAGENT LOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986107 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