BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 5900413 · Received August 24, 2016

    Report

    Report Number
    1823260-2016-01265
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 31, 2016
    Report Date
    August 24, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR PROCALCITONIN (ELECSYS BRAHMS PCT). THE ERRONEOUS RESULTS WERE GENERATED BETWEEN AN E601 ANALYZER AND AN E411 ANALYZER. THE CUSTOMER WAS TESTING ON THE E411 ANALYZER BECAUSE THE E601 ANALYZER THAT THEY NORMALLY USE WAS GENERATING ERROR MESSAGES. IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN WHICH RESULTS WERE CONSIDERED TO BE CORRECT. THIS MEDWATCH WILL COVER THE E411 ANALYZER. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE E601 ANALYZER. THE INITIAL RESULT FROM THE E601 ANALYZER WAS 0.85 NG/ML. ON (B)(6) 2016 THE SAMPLE WAS REPEATED ON THE E411 ANALYZER AND THE RESULT WAS 0.13 NG/ML. IT WAS NOTED THAT THIS SAMPLE HAD BEEN STORED AT ROOM TEMPERATURE. THE CUSTOMER WAS ADVISED TO RUN QUALITY CONTROLS (QC) AND REPEAT THE TESTS ON THE E411 ANALYZER. QC WAS ACCEPTABLE ON THE E411 ANALYZER. THE REPEAT RESULT FROM THE E411 ANALYZER WAS 0.13 NG/ML. ADDITIONAL RESULTS FROM ANOTHER SAMPLE WERE PROVIDED. IT IS NOT CLEAR IF THESE ARE FROM THE SAME PATIENT OR A DIFFERENT PATIENT. THE RESULT FROM THE E601 MODULE WAS 0.06 NG/ML. THE REPEAT RESULT FROM THE E411 ANALYZER WAS 0.02 NG/ML WITH A DATA FLAG. NO ADVERSE EVENT OCCURRED. THE ELECSYS BRAHMS PCT REAGENT LOT NUMBER WAS 121800-021 WITH AN EXPIRATION DATE OF 06/30/2017. IT WAS NOTED THAT QC WERE NOT RUN PRIOR TO THE RESULTS IN QUESTION. THE CUSTOMER PERFORMS QC ONCE A WEEK (AFTER LIQUID FLOW CLEANING (LFC) AND A WEEK AFTER LFC). IT IS NOT CLEAR IF THIS APPLIES TO THE E601 ANALYZER OR THE E411 ANALYZER. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE INVESTIGATION MADE NOTE OF THE STORAGE CONDITION OF THE SAMPLE USED ON THE E411 ANALYZER AND THE FREQUENCY OF QC MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552847 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1