BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 SYSTEM

    MDR report key: 5093975 · Received September 22, 2015

    Report

    Report Number
    1823260-2015-04203
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 22, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    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). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS FT3 RESULTS WERE IDENTIFIED BETWEEN A CENTAUR ANALYZER, AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT WAS REPORTED. THE FT3 REAGENT LOT NUMBER WAS 183221 WITH AN EXPIRATION DATE OF 01/31/2016. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THERE WAS NOT ENOUGH SAMPLE VOLUME LEFT TO COMPLETE THE INVESTIGATION. WHEN COMPARING VALUES FROM DIFFERENT TYPES OF ANALYZERS, VARIANCES CAN BE EXPECTED. FOR THYROID PARAMETERS, AGE, GENDER AND OTHER PATIENT CHARACTERISTICS SHOULD BE CONSIDERED WHEN COMPARING VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624196 COBAS E411 SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1