BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 5082257 · Received September 16, 2015

    Report

    Report Number
    1823260-2015-04176
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 30, 2015
    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

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER PROVIDED THE SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS FT4 AND FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E601 ANALYZER, AN ARCHITECT ANALYZER, AN E 170 ANALYZER USED AT THE INVESTIGATION SITE AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E 170 ANALYZER SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT3 REAGENT LOT NUMBER USED WITH THE E 170 ANALYZER AT THE INVESTIGATION SITE WAS 185694 WITH AN EXPIRATION DATE OF 05/31/2016. THE FT3 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER AT THE INVESTIGATION SITE WAS 183221 WITH AN EXPIRATION DATE OF 01/31/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S E601 ANALYZER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613987 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR