BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1960978 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00244
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 18, 2010
    Report Date
    February 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IN QUESTION WAS PROVIDED FOR INVESTIGATION. THE ELECSYS RESULTS ON THE SAMPLE WERE VERIFIED DURING THE INVESTIGATION. INTERFERENCE ANALYSIS REVEALED THE SAMPLE CONTAINED A HIGHLY SPECIFIC INTERFERING FACTOR TO THE INTERFERENCE BLOCKING AGENT USED IN THE CURRENT ASSAY. MOST LIKELY THIS INTERFERING FACTOR CAUSED THE FALSELY LOW FREE T4 RESULTS ON MODULAR E ANALYZER. THE FREE T3 MEASUREMENT WAS NOT AFFECTED BY THIS INTERFERING FACTOR. A ROOT CAUSE FOR THE DISCREPANT FREE T3 RESULTS WAS NOT IDENTIFIED. THE RESULTS OBTAINED FROM MODULAR E ANALYZER WERE NOT REPORTED OUTSIDE OF THE LAB. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR FREE TRIIODOTHYRONINE (FT3) AND FREE THYROXINE (FT4) ON THE ADDITIONAL E170 MODULE (E170) FOR ONE PATIENT SAMPLE. THE INITIAL FT3 RESULT WAS 8.3 PMOL/L, AND THE INITIAL FT4 RESULT WAS < 0.3 PMOL/L. ON (B)(6) 2010, THE SAMPLE WAS REPEATED ON A SIEMENS CENTAUR ANALYZER WHICH YIELDED A FT3 RESULT OF 6.78 PMOL/L AND A FT4 RESULT OF 15.31 PMOL/L. ON (B)(6) 2010, THE SAMPLE WAS REPEATED FOR FT4 BY THE ORIGINAL ANALYZER WHICH YIELDED A RESULT OF 2.3 PMOL/L. THE USER SAID THE PATIENT WAS NOT HARMED BY THE EVENT. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THIS DISCREPANCY. THE REAGENT LOT NUMBER FOR FT4 WAS 168156. THE REAGENT LOT NUMBER FOR FT3 WAS 158371.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 025 MO