BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA 19-9 ELECSYS E2G

    MDR report key: 11677478 · Received April 16, 2021

    Report

    Report Number
    1823260-2021-01158
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 26, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NIG
    PMA / PMN Number
    K050231
    Removal / Correction Number
    RES 84915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THERE WAS REAGENT CONTAMINATION, WHICH OCCURRED DURING THE FILLING PROCESS OF THE ELECSYS CA 19-9 REAGENT CASSETTES LOT NUMBER FOR THE COBAS E 801 MODULE ONLY. THE ISSUE IS RELATED TO CONTAMINATION OF THE REAGENT WITH MAGNETIC PARTICLES. A REPLACEMENT LOT IS NOT CURRENTLY AVAILABLE. ROCHE HAS PROVIDED TWO WORKAROUND OPTIONS TO CUSTOMERS. THE FIRST WORKAROUND IS CUSTOMERS MAY DISCONTINUE RUNNING THE ELECSYS CA 19-9 ASSAY ON THE E801 AND INSTEAD RUN THE CA 19-9 ASSAY ON THE COBAS E 411 ANALYZER, COBAS E 601 AND 602 MODULES, OR THE MODULAR ANALYTICS E 170 MODULE. THE SECOND WORKAROUND IS CUSTOMERS CAN CONTINUE TO RUN THE CA 19-9 ASSAY ON THE E801 AND REPEAT ALL RESULTS =37 U/ML WITHIN 2 HOURS. CUSTOMERS ARE ALSO INSTRUCTED TO USE ONLY THE FIRST 200 DETERMINATIONS OF THE 300 TEST COBAS E PACK. INSTRUCTIONS FOR IMPLEMENTING THESE WORKAROUNDS WERE COMMUNICATED TO CUSTOMERS BY CUSTOMER NOTIFICATION.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION AND QC WERE ACCEPTABLE. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULTS FOR TWO PATIENT SAMPLES FROM COBAS E 801 MODULE SERIAL NUMBER 1602-02. SAMPLE 1 INITIAL RESULT WAS 47.2 U/ML. THE REPEAT RESULT WAS 14.9 U/ML AND ON 26-MAR-2021, THE REPEAT RESULT WAS 15.0 U/ML. SAMPLE 2 INITIAL RESULT WAS 73.7 U/ML. THE REPEAT RESULT WAS 41.6 U/ML AND ON 26-MAR-2021, THE REPEAT RESULTS WERE 40.7 U/ML AND 40.0 U/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574390 CA 19-9 ELECSYS E2G CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM NIG ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G 50474301

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR