BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 6984339 · Received October 27, 2017

    Report

    Report Number
    1823260-2017-02444
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A TEMPORARY CONTAMINATION IN THE SIPPER LINE MAY HAVE INFLUENCED THE SAMPLE MEASUREMENT, BUT THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3), THE ELECSYS FT4 II ASSAY (FT4), AND THE ELECSYS TSH ASSAY (TSH) ON A COBAS 6000 E 601 MODULE (E601). NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED WITH THE SECONDARY TUBE OF THE SAMPLE. THE FIRST REPEAT WAS PERFORMED USING THE PRIMARY TUBE OF THE SAMPLE. THE SECOND REPEAT WAS PERFORMED USING THE SECONDARY TUBE OF THE SAMPLE. THE SAMPLE INITIALLY RESULTED WITH A FT3 VALUE OF 0.849 PMOL/L, THE FIRST REPEAT RESULT WAS 3.81 PMOL/L, THE SECOND REPEAT RESULT WAS 3.46 PMOL/L. THE SAMPLE INITIALLY RESULTED WITH A FT4 VALUE OF 0.144 NG/DL, THE FIRST REPEAT RESULT WAS 1.24 NG/DL, THE SECOND REPEAT RESULT WAS 1.19 NG/DL. THE SAMPLE INITIALLY RESULTED WITH A TSH VALUE OF 0.041 UIU/ML, THE FIRST REPEAT RESULT WAS 2.85 UIU/ML, THE SECOND REPEAT RESULT WAS 2.85 UIU/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE FT3 REAGENT LOT NUMBER WAS 203102, WITH AN EXPIRATION DATE OF DECEMBER 2017. THE FT4 REAGENT LOT NUMBER WAS 215455, WITH AN EXPIRATION DATE OF MARCH 2018. THE TSH REAGENT LOT NUMBER WAS 220841, WITH AN EXPIRATION DATE OF NOVEMBER 2017. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH CALIBRATION OR QUALITY CONTROLS. ONLY THIS SINGLE EVENT WAS REPORTED BY THE CUSTOMER. UPON INITIAL INVESTIGATION, IT WAS DETERMINED THAT THE ANALYZER MEASURING CELLS HAVE NOT BEEN REPLACED SINCE THE INSTALLATION OF THE ANALYZER IN MARCH 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764045 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1