BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4162045 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07788
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    December 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, THE SAMPLE WAS ALSO TESTED FOR ANTI-TSHR ON AN E601 ANALYZER AND E411 ANALYZER. THE ANTI-TSHR RESULT FROM THE E601 ANALYZER WAS 2.52, WHICH IS ABOVE THE REFERENCE RANGE. THE ANTI- TSHR RESULT FROM THE E411 ANALYZER WAS 1.70, WHICH IS WITHIN THE REFERENCE RANGE. THE UNITS OF MEASURE FOR THE ANTI-TSHR TEST WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE FROM THE PATIENT WAS INVESTIGATED FURTHER. TESTING HAS DETERMINED THAT AN INTERFERING FACTOR AGAINST STREPTAVIDIN WAS FOUND TO BE CONTAINED IN THE SAMPLE ALSO FOR THE TSH ASSAY. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE. OTHER REAGENT(S) INVOLVED IN THE COMPLAINT: BRAND NAME: TSH, THYROTROPIN. COMMON DEVICE NAME: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE. PRODUCT CODE: JLW. MANUFACTURER INFORMATION: SAME AS FOR FT3, FREE TRIIODOTHYRONINE. CATALOG NUMBER: 11731459122. LOT NUMBER: 179137. EXPIRATION DATE: 03/30/2015. MANUFACTURING SITE: SAME AS FOR FT3, FREE TRIIODOTHYRONINE. PMA/510(K)#: K961491.

    Additional Manufacturer Narrative · 1

    THE SAMPLE FROM THE PATIENT WAS INVESTIGATED FURTHER. FT3 AND FT4 WERE TESTED ON A COBAS E411 ANALYZER AND A COBAS E601 ANALYZER. FT3 AND FT4 RESULTS WERE FOUND SLIGHTLY ABOVE THE REFERENCE RANGE ON THE COBAS E411 ANALYZER. FT3 AND FT4 RESULTS WERE FOUND CLEARLY ABOVE THE REFERENCE RANGE ON THE COBAS E601 ANALYZER. TESTING HAS DETERMINED THAT AN INTERFERING FACTOR AGAINST STREPTAVIDIN WAS FOUND TO BE CONTAINED IN THE SAMPLE. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE. OTHER REAGENT(S) INVOLVED IN THE COMPLAINT: BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. PRODUCT CODE: CEC. (B)(4). PMA/510(K)#: K961489.

    Additional Manufacturer Narrative · 1

    A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2014 AND SENT FOR INVESTIGATION. FOR THE INVESTIGATION, THE SAMPLE WAS MEASURED WITH THE ELECSYS ASSAY ON COBAS 8000 ANALYZER SERIAL NUMBER (B)(4) AND E411 ANALYZER SERIAL NUMBER (B)(4) ON (B)(6) 2014. ON THE COBAS 8000 ANALYZER, THE RESULTS WERE 0.512 UIU/ML FOR TSH, 5.98 PG/ML FOR FT3, AND 2.35 PG/ML FOR FT4. ON THE E411 ANALYZER, THE RESULTS WERE 0.525 UIU/ML FOR TSH, 4.08 PG/ML FOR FT3, AND 1.75 NG/DL FOR FT4. FOR INVESTIGATION, THE SAMPLE WAS ALSO TESTED ON A CENTAUR ANALYZER ON (B)(6) 2014, RESULTING AS 1.5 UIU/ML FOR TSH, 2.9 PG/ML FOR FT3, AND 1.3 NG/DL FOR FT4. THE PATIENT SAMPLE FROM (B)(6) 2014 GENERATED SIMILAR RESULTS AS THE CUSTOMER'S MEASUREMENTS OF THE PREVIOUS PATIENT SAMPLE COLLECTED ON (B)(6) 2014. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S SAMPLE WAS COLLECTED ON (B)(6) 2014. THE REPEAT RESULTS WERE PRODUCED ON AN ABBOTT ARCHITECT ANALYZER. THE PATIENT'S INITIAL TSH RESULT WAS 0.37 UU/ML. THE REPEAT RESULT WAS 1.02 UU/ML. THE PATIENT'S INITIAL FT3 RESULT WAS 5.81 PG/ML. THE REPEAT RESULT WAS 2.51 PG/ML. THE PATIENT'S INITIAL FT4 RESULT WAS 1.92 NG/DL. THE REPEAT RESULT WAS 1.17 NG/DL. THE CUSTOMER PERFORMED A PEG PRECIPITATION TEST. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THERE WERE NO DEATHS ASSOCIATED WITH THE DISCREPANT RESULTS. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE FT3, FT4, AND TSH REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644657 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1