BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3153128 · Received June 8, 2013

    Report

    Report Number
    1823260-2013-03432
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION NEEDED FOR INVESTIGATION WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL WERE SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE EVENT. PATIENT 1: (B)(6) YEARS, MALE. PATIENT 2: (B)(6) YEARS, MALE. PATIENT 3: (B)(6), FEMALE. THE DATE OF THE EVENT WAS ACTUALLY (B)(6) 2013. FOR PATIENT 1, THE INITIAL RESULT WAS 4.38 NG/ML AND THE REPEAT RESULT WAS 14.25 NG/ML . THE PATIENT'S RESULT FROM THE PREVIOUS DAY WAS 15.2 NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE MB ISOENZYME OF CREATINE KINASE STAT(CK-MB) RESULTS ON THEIR E411 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS, THREE OF WHICH HAD DISCREPANT RESULTS. THE CUSTOMER STATED THAT ALL THE RESULTS WERE RELEASED. THE FIRST PATIENT'S INITIAL CK-MB RESULT WAS 15.2 NG/ML. ON (B)(6) 2013, THE REPEAT RESULT WAS 4.38 NG/ML. ON (B)(6) 2013, THE SECOND PATIENT'S INITIAL CK-MB RESULT WAS 0.3 NG/ML. THE FIRST REPEAT RESULT WAS 0.3 NG/ML. THE SECOND REPEAT RESULT WAS 28.5 NG/ML. THE THIRD REPEAT RESULT WAS 27.7 NG/ML. ON (B)(6) 2013, THE THIRD PATIENT'S INITIAL RESULT WAS 0.3 NG/ML. THE FIRST REPEAT RESULT WAS 9.44 NG/ML. THE SECOND REPEAT RESULT WAS 9.13 NG/ML. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE CK-MB REAGENT LOT NUMBER WAS 170570 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256044 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR