BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT4 III ASSAY

    MDR report key: 8686250 · Received June 11, 2019

    Report

    Report Number
    1823260-2019-02139
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 8, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K131244
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED TWO SAMPLES FOR INVESTIGATION. THE FT4 III RESULTS WERE MEASURED ABOVE THE REFERENCE RANGE. AN INTERFERING FACTOR AGAINST A COMPONENT OF THE REAGENT WAS IDENTIFIED. THIS TYPE OF INTERFERING FACTOR IS ADDRESSED IN THE PRODUCT LABELING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    RELEVANT TESTS,LABORATORY DATA WAS UPDATED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE E601 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT4 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 391521 WITH AN EXPIRATION DATE OF FEB-2020.

    Description of Event or Problem · 1

    THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 602 MODULE. THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT4 III (FT4 III), ELECSYS TSH ASSAY (TSH), ELECSYS FT4 II (FT4 II), ELECSYS FT3 III (FT3 III), ELECSYS ANTI-TSHR IMMUNOASSAY (ANTI-TSHR) AND ELECSYS ANTI-TPO (ANTI-TPO) BETWEEN THE CUSTOMER'S E602 MODULE, THE ARCHITECT METHOD, THE YAMASA METHOD, AND AN E601 MODULE USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TSHR RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S E602 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482635 ELECSYS FT4 III ASSAY RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS FT4 G3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1