BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 3810501 · Received May 14, 2014

    Report

    Report Number
    1823260-2014-03437
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, SHOULD BE (B)(6) 2014. THE PATIENT'S INITIAL FT4 RESULT WAS 25.98. THE CUSTOMER PROVIDED AN FT4 RESULT OF 27.52 FROM (B)(6) 2014. INFORMATION ON WHERE THIS RESULT CAME FROM WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL FT3 RESULT WAS 11.94. THE CUSTOMER PROVIDED AN FT3 RESULT OF 12.37 FROM (B)(6) 2014. INFORMATION ON WHERE THIS RESULT CAME FROM WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THE UNITS OF MEASURE FOR TSH, FT3, AND FT4 WERE MU/L AND PMOL/L. THE CUSTOMER STATED THE MAY HAVE RECEIVED CARBIMAZOLE, BUT IT WAS UNCERTAIN.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S HIGH FT3 AND FT4 RESULTS WERE REPRODUCED. AN INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED. THIS INTERFERENCE IS COVERED IN THE PRODUCT LABELING. OTHER REAGENT INVOLVED IN THE EVENT: BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. PRODUCT CODE: CEC. CATALOG NUMBER: 06437281190. LOT NUMBER: ASKU. EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR FT3 - FREE TRIIODOTHYRONINE. PMA/510(K)#: K961489.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH), FREE THYROXINE (FT4), AND FREE TRIIODOTHYRONINE (FT3) RESULTS FOR ONE PATIENT ON THEIR E-MODULE. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. THE INITIAL RESULTS WERE QUERIED BY THE CLINICIAN. THE CUSTOMER STATED THE IDENTICAL SAMPLE WAS THEN TESTED ON A CENTAUR PLATFORM AND A DELFIA PLATFORM. THE PATIENT'S INITIAL TSH RESULT WAS 3.29. THE RESULT FROM THE CENTAUR PLATFORM WAS 4.41. THE RESULT FROM THE DELFIA PLATFORM WAS 4.55. THE PATIENT'S INITIAL FT4 RESULT WAS 26.0. THE RESULT FROM THE CENTAUR PLATFORM WAS 14.5. THE RESULT FROM THE DELFIA PLATFORM WAS 11.5. THE PATIENT'S INITIAL FT3 RESULT WAS 11.9. THE RESULT FROM THE CENTAUR PLATFORM WAS 3.8. THE RESULT FROM THE DELFIA PLATFORM WAS 4.7. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE TSH, FT4, AND FT3 REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288698 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR CARBIMAZOLE