BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4447627 · Received January 23, 2015

    Report

    Report Number
    1823260-2015-00570
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE, IN THE ORIGINAL SAMPLE TUBE, INITIALLY RESULTED AS 26 NG/ML. THE SAME SAMPLE TUBE WAS REPEATED AND RESULTED AS 1 NG/ML. THE SAMPLE WAS TRANSFERRED TO A SAMPLE CUP AND REPEATED A SECOND TIME, RESULTING AS 1 NG/ML. THE PATIENT'S PREVIOUS MEASUREMENT WAS ABOUT 1 NG/ML. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE CEA REAGENT LOT NUMBER WAS 180517 WITH AN EXPIRATION OF JANUARY 2016. THE ANALYZER HAD A PERIODIC MAINTENANCE CHECK ON 12/18/2014 AND NO PROBLEMS WERE FOUND. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR INVESTIGATION WAS ASKED FOR, BUT NOT PROVIDED. THERE WAS NO INDICATION OF A GENERAL ISSUE WITH THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55078 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR