BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 5391010 · Received January 26, 2016

    Report

    Report Number
    1823260-2016-00077
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    December 28, 2015
    Report Date
    March 1, 2016
    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).

    Additional Manufacturer Narrative · 1

    THE FT4 REAGENT LOT NUMBER WAS 183473.A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR FREE THYROXINE (FT4). THE SAMPLE INITIALLY RESULTED AS 0.212 NG/DL AND THIS VALUE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING AS 1.41 NG/DL. THE 1.41 NG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FT4 REAGENT LOT NUMBER WAS ASKED FOR, BUT NOT PROVIDED. THE FT4 REAGENT EXPIRATION DATE WAS 08/31/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49971 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1