BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7082018 · Received December 5, 2017

    Report

    Report Number
    1823260-2017-02834
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. POSSIBLE CAUSES INCLUDE FOAM OR BUBBLES ON THE SAMPLE SURFACE, TILTED TUBES IN COMBINATION WITH WET TUBE WALLS, OR FIBRIN CLOTS OR STRANDS CAUSED BY INSUFFICIENT PRE-ANALYTICAL HANDLING. OTHER TYPICAL CAUSES FOR THIS TYPE OF EVENT INCLUDE ISSUES WITH SAMPLE QUALITY OR INSUFFICIENT ANALYZER MAINTENANCE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW ELECSYS TSH ASSAY AND ELECSYS FT4 RESULTS FOR ONE PATIENT SAMPLE. THE SAMPLE WAS REPEATED ON (B)(6) 2017. THE INITIAL TSH RESULT WAS 0.046 MIU/L AND THE REPEAT RESULT WAS 1.81 MIU/L. THE INITIAL FT4 RESULT WAS 2.06 PMOL/L AND THE REPEAT RESULT WAS 20.45 PMOL/L. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULTS MATCHED THE REPEAT RESULTS. NO SPECIFIC DATA WAS PROVIDED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TSH REAGENT LOT NUMBER WAS 220841. THE EXPIRATION DATE WAS NOV-2017. THE FT4 REAGENT LOT NUMBER WAS 215455. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE CALIBRATION AND QC DATA WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861986 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR