BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 4476386 · Received February 2, 2015

    Report

    Report Number
    1823260-2015-00785
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    January 13, 2015
    Report Date
    February 18, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE THYROTROPIN (TSH) ASSAY.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS ON A SIEMENS CENTAUR ANALYZER. A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROTROPIN (TSH) AND FREE THYROXINE (FT4) RESULTS FOR ONE PATIENT FROM THE COBAS E601 ANALYZER SERIAL NUMBER 2440-15. THE INITIAL TSH RESULT WAS APPROXIMATELY 1.3 UUI/ML AND FT4 RESULT WAS APPROXIMATELY 30 PMOL/L. ON (B)(6) 2015, TWO SAMPLES FROM THE PATIENT DRAWN ON (B)(6) 2015 WERE TESTED. IT WAS UNKNOWN IF EITHER OF THESE SAMPLES WAS THE SAMPLE THAT WAS USED TO GENERATE THE INITIAL RESULTS. SAMPLE 1 COLLECTED IN THE MORNING, TSH RESULT WAS 2.62 UUI/ML AND FT4 WAS 32.68 PMOL/L. SAMPLE 2 COLLECTED IN THE AFTERNOON, TSH RESULT WAS 1.39 UUI/ML AND FT4 WAS 66.71 PMOL/L. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENT WAS REPORTED. SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S HIGH FT4 RESULTS WERE REPRODUCED. THE TSH RESULTS WERE FOUND TO BE WITHIN THE REFERENCE RANGE. NO INTERFERING FACTOR TO STREPTAVIDIN WAS FOUND IN THE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75645 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 179279

    Patients

    Seq Age Sex Outcome Treatment
    1 025 MO