BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4869273 · Received June 25, 2015

    Report

    Report Number
    1823260-2015-03714
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CLEANED AND ADJUSTED MULTIPLE PARTS OF THE ANALYZER AND FOUND KINKED TUBING ON THE PRE-CLEAN LINE. THE CUSTOMER MENTIONED THAT AROUND THE TIME OF THE EVENT A PROCELL WAS REPLACED BUT THE LIFTER WASN'T RETURNED TO THE DOWN POSITION. THE FIELD SERVICE ENGINEER RAN ANALYZER TESTS AND ALL WERE WITHIN SPECIFICATION. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE ROOT CAUSE OF THE ERRONEOUS HIGH FT4 RESULTS IS MOST LIKELY DUE TO THE KINKED TUBING THAT WAS IDENTIFIED ON THE PRE-CLEAN LINE. THIS CAN LEAD TO AN INSUFFICIENT VOLUME OF PRECLEAN M IN THE ASSAY CUP CAUSING THE ELEVATED RESULTS FOR FT4 TESTS. NO FURTHER ISSUES HAVE OCCCURRED SINCE THE FIELD SERVICE ENGINEER SERVICED THE ANALYZER.

    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 9 PATIENT SAMPLES TESTED FOR FREE THYROXINE (FT4). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. PATIENT SAMPLE 1 INITIAL FT4 RESULT WAS 71.1 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 11.76 PMOL/L. PATIENT SAMPLE 2 (B)(6) INITIAL FT4 RESULT WAS 56.8 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 15.43 PMOL/L. PATIENT SAMPLE 3 (B)(6) INITIAL FT4 RESULT WAS 44.2 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 16.26 PMOL/L. PATIENT SAMPLE 4 (B)(6) INITIAL FT4 RESULT WAS 67.4 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 12.03 PMOL/L. PATIENT SAMPLE 5 (B)(6) INITIAL FT4 RESULT WAS 34.7 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 16.17 PMOL/L. PATIENT SAMPLE 6 (B)(6) INITIAL FT4 RESULT WAS 28.42 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 14.45 PMOL/L. PATIENT SAMPLE 7 (B)(6) INITIAL FT4 RESULT WAS > 100 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 17.23 PMOL/L. PATIENT SAMPLE 8 (B)(6) INITIAL FT4 RESULT WAS > 100 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 15.08 PMOL/L. PATIENT SAMPLE 9 (B)(6) INITIAL FT4 RESULT WAS > 100 PMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 18.15 PMOL/L. IT IS NOT KNOWN IF ANY PATIENTS WERE ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE REPORTED. THE FT4 REAGENT LOT NUMBER WAS 183473. THE EXPIRATION DATE WAS NOT PROVIDED. THE MEASURING CELLS WERE REPLACED 1 MONTH AGO. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411107 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR