BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 7128182 · Received December 19, 2017

    Report

    Report Number
    1823260-2017-02987
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPIRATION DATE FOR THE CA 19-9 REAGENT LOT IN USE WAS OCT-2018. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. CALIBRATION AND QC WERE ACCEPTABLE. SEVERAL "ABNORMAL SAMPLE ASPIRATION" MESSAGES FROM THE DAY OF THE EVENT WERE OBSERVED DURING A REVIEW OF THE ALARM TRACE. THE CUSTOMER USED A 13X75 SAMPLE TUBE WITHOUT A RACK ADAPTER. POSSIBLE ROOT CAUSES FOR THE ISSUE MAY BE RELATED TO THE CUSTOMER NOT USING A RACK ADAPTER FOR THE 13MM SAMPLE TUBE OR BUBBLES OR FOAM ON THE SAMPLE SURFACE. ADDITIONAL POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY AND INSUFFICIENT MAINTENANCE. A GENERAL PRODUCT PROBLEM HAS BEEN EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR 1 PATIENT TESTED FOR ELECSYS CA 19-9 IMMUNOASSAY (CA 19-9) ON A COBAS 8000 E 602 MODULE. THE INITIAL CA 19-9 RESULT FROM AN ALIQUOT TUBE WAS 14.6 KU/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017 THE CUSTOMER REPEATED THE SAMPLE ON THE SAME E602 MODULE AND THE RESULT WAS 5678 KU/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CA 19-9 REAGENT LOT NUMBER WAS 231612. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER STATED ALL INSTRUMENT MAINTENANCE IS UP TO DATE. LIQUID FLOW CLEANING IS PERFORMED WEEKLY AND PINCH TUBING WAS CHANGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906938 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR