BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2016-00203

    MDR report key: 5454924 · Received February 23, 2016

    Report

    Report Number
    1823260-2016-00203
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    January 1, 2016
    Report Date
    March 17, 2016
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LACK OF SAMPLE VOLUME, FURTHER INVESTIGATION OF ANTI-TSHR COULD NOT BE PERFORMED. THE ELEVATED ANTI-TSHR VALUES COULD BE AFFECTED BY THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR PREVIOUSLY IDENTIFIED FOR THE FT4 AND FT3 PARAMETERS. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THYROID TESTS RUN BY THE ROCHE METHOD DID NOT MEET THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR FREE THYROXINE (FT4 II), FREE TRIIODOTHYRONINE (FT3), TRIIODOTHYRONINE (T3), THYROXINE (T4) AND ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR). THE THYROID VALUES FROM THE ABBOTT METHOD WERE NORMAL. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A CUSTOMER IN PORTUGAL SENT THE PATIENT SAMPLE ALONG WITH AN EMAIL TO A BIOCHEMIST IN A (B)(6). INFORMATION REGARDING THIS EVENT CAME TO THE MANUFACTURER FROM THE (B)(6). THE MANUFACTURER IS ATTEMPTING TO GATHER MORE DETAILS. THIS MEDWATCH WILL COVER ANTI-TSHR. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT4 II ERRONEOUS RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE T3 ERRONEOUS RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE T4 ERRONEOUS RESULTS. TESTING PERFORMED BY THE PORTUGESE CUSTOMER DETERMINED THE FT4 II AND FT3 RESULTS WERE VERY HIGH, THE T3 AND T4 RESULTS WERE 3-4 TIMES THE NORMAL RANGE AND THE ANTI-TSHR RESULTS WERE 10 TIMES THE NORMAL RANGE WITH THE ROCHE METHOD. THE TSH RESULTS FOR THIS PATIENT WERE NORMAL WITH THE ROCHE METHOD AND HER PAST THYROID FUNCTION WAS NORMAL. THE PATIENT HAS NO SYMPTOMS OF HYPERTHYROIDISM. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE SAMPLE. THE (B)(6) HOSPITAL TESTED THE SAMPLE ON AN ABBOTT ARCHITECT I2000 AND THE FT3, FT4 II AND TSH VALUES WERE NORMAL. THE ACTUAL RESULTS WERE NOT PROVIDED. THE ANTI-TSHR RESULT FROM THE RIA BRAHMS METHOD WAS 1.9 UL/L WHICH IS IN THE GREY ZONE OF THAT ASSAY. THE SAMPLE WAS ALSO TREATED WITH HBT SCANTIBODIES AND TESTED FOR HUMAN ANTI-MOUSE ANTIBODIES (HAMA) AND THE RESULT WAS NEGATIVE. NO REPEAT TEST RESULTS HAVE BEEN PROVIDED FOR THE T3 AND T4 TESTS. NO ADVERSE EVENT OCCURRED. THE TESTS BY THE ROCHE METHOD WERE PERFORMED ON AN E601 ANALYZER. THE SERIAL NUMBER WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1