BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7312597 · Received March 5, 2018

    Report

    Report Number
    1823260-2018-00644
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 11, 2018
    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 · 0

    THE CUSTOMER HAS NOT HAD ANY ADDITIONAL ISSUES SINCE THE SAMPLE PROBE WAS REPLACED BY THE FSE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY (TSH), ELECSYS FT3 III (FT3 III) AND ELECSYS FT4 II ASSAY (FT4 II) ON A COBAS 6000 E 601 MODULE. THE INITIAL TSH RESULT WAS < 0.01 UIU/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.04 UIU/ML AND < 0.01 UIU/ML. THE INITIAL FT4 II RESULT WAS > 7.77 NG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.16 NG/DL AND > 7.77 NG/DL. THE INITIAL FT3 III RESULT WAS 23.62 PG/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.96 PG/ML AND 23.49 PG/ML. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN CONSIDERED THE PATIENT'S CLINICAL SYMPTOMS AND THOUGHT THE INITIAL AND 2ND REPEAT RESULTS WERE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 270308. THE FT3 III REAGENT LOT NUMBER WAS 242379. THE FT4 II REAGENT LOT NUMBER WAS 225129. NO REAGENT EXPIRATION DATES WERE PROVIDED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND ADJUSTED THE POSITION OF THE SAMPLE PROBE, THE CHIP BUFFER PLATE AND THE GRIPPER. FOLLOWING THIS VISIT, THE CUSTOMER CONTINUED TO HAVE ISSUES. THE FSE RETURNED TO THE CUSTOMER SITE AND REPLACED THE SAMPLE PROBE. INSTRUMENT PERFORMANCE TESTING WAS COMPLETED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158369 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1