BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 5221080 · Received November 12, 2015

    Report

    Report Number
    1823260-2015-04533
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    May 20, 2015
    Report Date
    December 29, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION.THE FT4 VALUES GENERATED AT THE CUSTOMER SITE COULD NOT BE CONFIRMED WITH THE MEASUREMENTS RECEIVED DURING THE INVESTIGATION. THE FT4 VALUES WERE IN THE NORMAL REFERENCE RANGE. NO REAGENT SPECIFIC ISSUE COULD BE IDENTIFIED IN THE INVESTIGATED SAMPLE. UPON VISUAL INSPECTION OF THE SAMPLE, NO CLOTS OR FIBRIN FILAMENTS WERE DETECTED. IT WAS RECOMMENDED TO CHECK THE PRE-ANALYTIC PROCEDURE AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    QUALITY CONTROLS WERE ACCEPTABLE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. A PRE-ANALYTICAL ISSUE CANNOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR FREE THYROXINE (FT4 II). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL FT4 II RESULT FROM THE E602 ANALYZER WAS 0.68 NG/DL. THE PATIENT ALSO HAD A TSH RESULT AT THIS TIME OF 6.20 MU/L. BOTH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT WAS MADE FROM THE PRIMARY TUBE AND THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT INSTRUMENT AND THE FT4 RESULT WAS 1.16 NG/DL. NO ADVERSE EVENT OCCURRED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750753 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 183473

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR