BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3893778 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04651
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 25, 2014
    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).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3), THYROTROPIN (TSH), AND FT4 RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER NOTICED ERROR MESSAGES WITH CALIBRATING TSH AND A SUDDEN SIGNAL DROP OBSERVED WITH THE CALIBRATION. PATIENT SAMPLES FROM THE PREVIOUS WEEK WERE QUESTIONED AS "UNBALANCED VALUES" OF TSH, FT3 AND FT4 WERE REPEATED. THE CUSTOMER PROVIDED DATA FOR NINE PATIENTS, SEVEN OF WHICH HAD DISCREPANT RESULTS FOR FT3 OR TSH THAT WERE REPORTED OUTSIDE THE LABORATORY. THE FIRST PATIENT'S INITIAL FT3 RESULT OF 4.86 PG/ML. THE REPEAT RESULT WAS 2.57 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 2.72 PG/ML. THE SECOND PATIENT'S INITIAL FT3 RESULT WAS 5.18 PG/ML. THE REPEAT RESULT WAS 2.78 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 2.77 PG/ML. THE THIRD PATIENT'S INITIAL THS RESULT WAS <0.010 UIU/ML. THE REPEAT RESULT WAS 0.016 UIU/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 0.016 UIU/ML. THE THIRD PATIENT'S INITIAL FT3 RESULT WAS 6.42 PG/ML. THE REPEAT RESULT WAS 3.20 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 3.34 PG/ML. THE FOURTH PATIENT'S INITIAL FT3 RESULT WAS 5.26 PG/ML. THE REPEAT RESULT WAS 2.39 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 2.50 PG/ML. THE FIFTH PATIENT'S INITIAL TSH RESULT WAS 0.676 UIU/ML. THE REPEAT RESULT WAS 1.38 UIU/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 1.38 UIU/ML. THE FIFTH PATIENT'S INITIAL FT3 RESULT WAS 5.3 PG/ML. THE REPEAT RESULT WAS 2.34 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 2.44 PG/ML. THE SIXTH PATIENT'S INITIAL TSH RESULT WAS 0.846 UIU/ML. THE REPEAT RESULT WAS 1.55 UIU/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 1.52 UIU/ML. THE SIXTH PATIENT'S INITIAL FT3 RESULT WAS 4.41 PG/ML. THE REPEAT RESULT WAS 2.09 PG/ML. THE SAMPLE WAS REPEATED IN ANOTHER E601 ANALYZER AND THE RESULT WAS 2.08 PG/ML. ON (B)(6) 2014, THE SEVENTH PATIENT'S INITIAL FT3 RESULT WAS 5.30 PG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT. THE REPEAT RESULT WAS 2.27 PG/ML. THERE HAVE BEEN NO REPORTS OF ANY ADVERSE EVENTS REGARDING THE FIRST SIX PATIENTS. THE SEVENTH PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE FT3 REAGENT LOT NUMBER WAS 175509 AND THE EXPIRATION DATE WAS 10/30/2014. THE TSH REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE AND CHECKED THE ANALYZER. HE CHANGED THE MEASURING CELL AND FLUIDICS RELATED PARTS INCLUDING THE VALVE TUBE. AFTER MAINTENANCE, CALIBRATION AND QUALITY CONTROL WERE PERFORMED AND REPEATABILITY OF TSH, FT4, AND FT3 WAS CHECKED. NO REPORTS OF REOCCURRENCES HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371320 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1