BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4232885 · Received November 6, 2014

    Report

    Report Number
    1823260-2014-08659
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    May 28, 2014
    Report Date
    April 18, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO CONFIRM THE TSH VALUE GENERATED BY THE CUSTOMER. A VALUE WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY WAS MEASURED. THE REASON FOR THE DIFFERENT VALUES GENERATED WITH THE ROCHE TSH ASSAY AND THE SIEMENS CENTAUR ANALYZER METHOD CANNOT BE EXPLAINED. FURTHER CLARIFICATIONS OF THE OBSERVED DISCREPANCIES IS NOT POSSIBLE WITH AVAILABLE TESTING METHODS.

    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

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER HAS PROVIDED A PATIENT DATE OF BIRTH OF (B)(6). A CLARIFICATION OF THIS DATE HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DATE OF BIRTH WAS CONFIRMED TO BE (B)(6) 1997. 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

    AN ADDITIONAL SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE SAMPLE WAS FOUND TO CONTAIN AN INTERFERENCE FACTOR TO STREPATVIDIN, WHICH WOULD CREATE FALSELY ELEVATED VALUES FOR ANTIBODY TO THYROGLOBULIN (ANTI-TG), ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR), FT3, AND FT4. THE INTERFERENCE IS COVERED IN THE RESPECTIVE PRODUCT LABELING FOR THESE ASSAYS. THE CUSTOMER SENT THE SAMPLE TO A THIRD LABORATORY, "LAM BIOMNIS", WHERE IT WAS TESTED FOR 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 TSH ASSAY. THE FIRST SAMPLE FROM THE PATIENT, FROM (B)(6) 2014, WAS INITIALLY TESTED AT THE (B)(6) SITE AND THESE RESULTS WERE GIVEN TO THE PATIENT AND ENDOCRINOLOGIST. THE ENDOCRINOLOGIST TOLD THE PATIENT TO GO TO THE (B)(6) SITE FOR TESTING WITH OTHER METHODS. THE (B)(6) SITE HAS ANOTHER E602 ANALYZER, A CENTAUR XP ANALYZER, AND A BECKMAN DXI ANALYZER. THE PATIENT WENT TO THE (B)(6) SITE IN (B)(6), WHERE A SECOND SAMPLE WAS DRAWN FROM THE PATIENT ON (B)(6) 2014. THE (B)(6) SITE ASKED THE (B)(6) SITE TO SEND THE SAMPLE FROM (B)(6) 2014. THE BIOLOGIST FROM (B)(6) 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 (B)(6) SITE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713641 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR THIAMAZOL