BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3232603 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04324
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHX
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. CALIBRATION AND QUALITY CONTROL DATA SHOW NO INDICATION OF AN ISSUE WITH THE SYSTEM, REAGENT, OR CALIBRATOR. BASED UPON THE INFORMATION PROVIDED, IT IS LIKELY THAT THE ISSUE IS RELATED TO PRE-ANALYTIC HANDLING AS THE CUSTOMER RE-USED A SAMPLE CUP THAT HAD ALREADY BEEN USED WHEN RUNNING THE SAMPLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE SAMPLE INITIALLY RESULTED AS 7.26 NG/ML. THE SAMPLE WAS REPEATED AND RESULTED AS 3.18 NG/ML. THE VALUE OF 7.26 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR COMPLAINED, SO THE CUSTOMER PULLED THE SAMPLE FROM THE FREEZER ON (B)(6) 2013 AND REPEATED IT TWICE. THE FIRST REPEAT PERFORMED ON (B)(6) 2013 RESULTED AS 3.42 NG/ML AND THE SECOND REPEAT RESULTED AS 3.39. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CEA REAGENT LOT NUMBER WAS 170257. THE EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333803 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR