BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 5900243 · Received August 24, 2016

    Report

    Report Number
    1823260-2016-01264
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 30, 2016
    Report Date
    August 24, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    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 E601 ANALYZER. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE E411 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. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND PERFORMED A MAINTENANCE CHECK OF THE E601 SYSTEM. ERROR MESSAGES WERE OBSERVED. A TUBE NEAR THE WATER SUPPLY TANK WAS BROKEN. THE FSE CONFIRMED CLEANING WATER, LIQUID LEVEL DETECTION PRESSURE AND PRESSURE SENSOR. THE TUBE WAS EXCHANGED AND THE CUSTOMER HAS NOT HAD ANY FURTHER PROBLEMS WITH THE E601 ANALYZER SINCE THIS SERVICE ACTION. THE FSE IDENTIFIED A LEAK IN THE WATER SUPPLY TUBING. THE INVESTIGATION NOTED THAT THIS AFFECTS THE WATER SUPPLY TO THE ANALYZER AND CAN CAUSE CARRYOVER AT THE REAGENT PIPETTE, SIPPERS AND MEASURING CELL. THIS CAN ALSO CAUSE IMPRECISION IN SAMPLE PIPETTING. THE ALARM MESSAGES OBSERVED BY THE FSE SUPPORT THESE POTENTIAL ROOT CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553226 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1