BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4232886 · Received November 6, 2014

    Report

    Report Number
    1823260-2014-08657
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    May 28, 2014
    Report Date
    April 18, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    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). THE CUSTOMER HAS PROVIDED A PATIENT DATE OF BIRTH OF (B)(6) 1197. A CLARIFICATION OF THIS DATE HAS BEEN REQUESTED. REFERENCE THE MEDWATCHES WITH PATIENT IDENTIFIERS OF (B)(6) FOR ADDITIONAL DATA RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS HAVE DETERMINED THAT THE SAMPLE CONTAINS AN INTERFERING FACTOR TO STREPTAVIDIN PRESENT IN THE REAGENT. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE.

    Additional Manufacturer Narrative · 1

    TWO SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. DURING THE INVESTIGATION, FT3 RESULTS WERE FOUND TO BE ABOVE THE REFERENCE RANGE WHEN THE SAMPLES WERE TESTED ON A COBAS E601 ANALYZER AND COBAS E411 ANALYZER. THE FT3 RESULTS ON THE COBAS E601 WERE SIGNIFICANTLY HIGHER THAN THE RESULTS ON COBAS E411. FT4 RESULTS WERE FOUND WITHIN REFERENCE RANGE ON COBAS E411 AND ABOVE REFERENCE RANGE ON COBAS E601. IT WAS DETERMINED THAT THE SAMPLES HAD AN INTERFERING FACTOR TO STREPTAVIDIN PRESENT IN THE REAGENT. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. FURTHER INVESTIGATION WAS PERFORMED ON THE PATIENT SAMPLE. THE SAMPLE WAS PRECIPITATED AND, THEREAFTER, THE FT4, FT3, ANTI-TPO AND ANTI-TG PARAMETERS WERE MEASURED WITH ASSAYS FROM ROCHE. PER INPUT FROM THE CUSTOMER, NORMAL RESULTS WERE MEASURED. FROM INTERPRETATION OF THE RESULTS, THE CUSTOMER STATED THAT THERE WAS THE PRESENCE OF AN IGG ANTIBODY AGAINST STREPTAVIDIN. STREPTAVIDIN INTERFERENCE HAS BEEN IDENTIFIED IN THE PATIENT'S SAMPLE AND IS DOCUMENTED IN PRODUCT LABELING. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DATE OF BIRTH WAS CONFIRMED TO BE (B)(6). PREVIOUS RESULTS FOR THE PATIENT WERE ALSO PROVIDED. ALL PREVIOUS RESULTS WERE OBTAINED WITH ROCHE ELECSYS ASSAYS. THE PATIENT HAD A T4L RESULT OF 20.1 NG/L, A TSH RESULT OF 0.49 MUI/L, AND AN ANTI-TSHR RESULT OF 14.12 UI/L ON (B)(6) 2013. THE PATIENT HAD A T3L RESULT OF 6.4 NG/L, A T4L RESULT OF 20.7 NG/L, A TSH RESULT OF 0.48 MUI/L, AN ATG RESULT OF 246 UI/ML, AND A TPO RESULT OF 295.4 UI/ML ON (B)(6) 2013. THE PATIENT HAD A T3L RESULT OF 5.2 NG/L, A T4L RESULT OF 23 NG/L, AND A TSH RESULT OF 0.42 MUI/L ON (B)(6) 2013. THE PATIENT HAD A T3L RESULT OF 6.3 NG/L, A T4L RESULT OF 32.2 NG/L, AND A TSH RESULT OF 0.46 MUI/L ON (B)(6) 2013. THE PATIENT HAD A T3L RESULT OF 5.7 NG/L, A T4L RESULT OF 34.9 NG/L, AND A TSH RESULT OF 1.07 MUI/L ON (B)(6) 2014. THE PATIENT HAD A T3L RESULT OF 4.5 NG/L, A T4L RESULT OF 24.8 NG/L, AND A TSH RESULT OF 0.71 MUI/L ON (B)(6) 2014. THE PATIENT HAD A T3L RESULT OF 5.6 NG/L, A T4L RESULT OF 26.5 NG/L, AND A TSH RESULT OF 0.71 MUI/L ON (B)(6) 2014. THE PATIENT HAD A T3L RESULT OF 6.3 NG/L, A T4L RESULT OF 34.1 NG/L, AND A TSH RESULT OF 0.4 MUI/L ON (B)(6) 2014. THE PATIENT HAD A T3L RESULT OF 5.9 NG/L, A T4L RESULT OF 19.9 NG/L, AND A TSH RESULT OF 0.39 MUI/L ON (B)(6) 2014. THE PATIENT HAD A T4L RESULT OF 26.4 NG/L AND A TSH RESULT OF 0.8 MUI/L ON (B)(6) 2014. ACCORDING TO ALL RESULTS, THE PATIENT WAS DIAGNOSED AS HAVING A BASEDOW DISEASE AND IS UNDER TREATMENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT THE SAMPLE TO A THIRD LABORATORY, (B)(4)., WHERE IT WAS TESTED FOR ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR). THE ANTI-TSHR RESULT WAS POSITIVE. THE CUSTOMER HAS CLARIFIED THAT THE PATIENT WAS DIAGNOSED AND TREATED FOR GRAVE'S DISEASE BASED ON THE RESULTS OF THE ELECSYS THYROID TESTS (FT4, FT3, TSH). THE CUSTOMER WAS "NOT OK" WITH THE DIAGNOSIS. THE PATIENT WAS NOT ADVERSELY AFFECTED DUE TO BEING TREATED FOR GRAVE'S DISEASE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE ARE ERRONEOUS RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED FOR FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND THYROTROPIN (TSH). DISCREPANCIES FOR THESE ASSAYS WERE SEEN WHEN RESULTS WERE COMPARED FROM THE E602 ANALYZER, A CENTAUR XP ANALYZER, AND A BECKMAN DXI ANALYZER. THIS MEDWATCH WILL REFERENCE THE FT3 ASSAY. THE FIRST SAMPLE FROM THE PATIENT, FROM (B)(6) 2014, WAS INITIALLY TESTED AT THE LAM LABAZUR CHETEAULIN SITE AND THESE RESULTS WERE GIVEN TO THE PATIENT AND ENDOCRINOLOGIST. THE ENDOCRINOLOGIST TOLD THE PATIENT TO GO TO THE CHU RENNES SITE FOR TESTING WITH OTHER METHODS. THE CHU RENNES SITE HAS ANOTHER E602 ANALYZER, A CENTAUR XP ANALYZER, AND A BECKMAN DXI ANALYZER. THE PATIENT WENT TO THE CHU RENNES SITE IN (B)(6), WHERE A SECOND SAMPLE WAS DRAWN FROM THE PATIENT ON (B)(6) 2014. THE CHU RENNES SITE ASKED THE LAM LABAZUR CHETEAULIN SITE TO SEND THE SAMPLE FROM (B)(6) 2014. THE BIOLOGIST FROM CHU RENNES TESTED BOTH SAMPLES AND CALLED BACK THE ENDOCRINOLOGIST TO LET HER KNOW THAT DISCREPANCIES EXIST. REFER TO THE ATTACHMENT FOR ALL SAMPLE RESULTS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER FOR THE E602 ANALYZER AT THE LAM LABAZUR CHETEAULIN SITE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712807 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 177312

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR THIAMAZOL