BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3082078 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02589
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS COULD NOT DETERMINE A SPECIFIC ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESULTS THEY RECEIVED FOR A MULTIPLE NUMBER OF PATIENT SAMPLES TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA) AND CARBOHYDRATE ANTIGEN 19-9 HAVE NOT BEEN CONSISTENT OVER TIME. THE CUSTOMER PROVIDED DATA FOR THREE PATIENT SAMPLES AND OF THESE THREE, ONE WAS FOUND TO HAVE AN ERRONEOUS RESULT FOR CEA. THE SAMPLE INITIALLY RESULTED AS 7.3 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2013, RESULTING AS 3.1 NG/ML AND AN AMENDED REPORT WAS ISSUED FOR THIS VALUE. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CEA REAGENT LOT NUMBER WAS 17025704 WITH AN EXPIRATION DATE OF (B)(6) 2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE COMPLETED PERFORMANCE TESTING AND THIS PASSED WITH NO ERRORS. HE ALSO PERFORMED A SYSTEM VOLUME CHECK AND PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185157 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR