BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 3921872 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05011
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED AS THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE FREE THYROXINE (FT4) GEN 2 RESULTS FOR ONE PATIENT FROM A COBAS E602 ANALYZER. THE PATIENT IS TESTED ONCE A MONTH FOR FT4. ON (B)(6) 2014, THE RESULT FOR THE PATIENT WAS >7.77 NG/DL. THE USER DILUTED THE SAMPLE AND RECEIVED A RESULT OF 41.5 NG/DL. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 DUE TO THE RESULT. ON (B)(6) 2014, THE RESULT FOR A NEW SAMPLE FROM THE PATIENT WAS >7.77 NG/DL. THE USER DILUTED THE SAMPLE AND RECEIVED A RESULT OF 34 NG/DL. ON (B)(6) 2014, THIS SAMPLE WAS TESTED ON AN ABBOTT ARCHITECT ANALYZER AND THE RESULT WAS 4.24 NG/DL. INFORMATION WAS REQUESTED REGARDING IF THE PATIENT WAS ADVERSELY AFFECTED, BUT THIS WAS NOT PROVIDED. PRODUCT LABELING STATES SAMPLES FOR FT4 DETERMINATIONS CANNOT BE DILUTED, AS T4 IN THE BLOOD IS PRESENT IN FREE AND PROTEIN-BOUND FORMS WHICH ARE IN EQUILIBRIUM. A CHANGE IN THE CONCENTRATION OF THE BINDING PROTEINS ALTERS THIS EQUILIBRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399400 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 17624500

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR CAMEN TAB| INDENOL TAB