BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4996686 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03962
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 17, 2015
    Report Date
    September 23, 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

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS OF THE SAMPLE HAVE DETERMINED THAT THE SAMPLE CONTAINS AN INTERFERING FACTOR TO THE STREPTAVIDIN PRESENT IN THE REAGENT. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). OF THE THREE TESTS, THE SAMPLE HAD ERRONEOUS RESULTS FOR FT3 AND FT4. IT WAS ASKED, BUT THE DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER FT3. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REFERRING TO FT4. THE SAMPLE WAS INITIALLY TESTED AT THE CUSTOMER SITE ON AN E602 ANALYZER AND THEN REPEATED ON A CENTAUR ANALYZER. DURING INVESTIGATIONS, THE PATIENT SAMPLE WAS TESTED ON AN E170 ANALYZER AND AN E411 ANALYZER. REFER TO THE ATTACHMENT FOR THE SPECIFIC PATIENT RESULT VALUES. IT WAS ASKED, BUT IT IS UNKNOWN WHICH PATIENT RESULTS, IF ANY, WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE E602 ANALYZER SERIAL NUMBER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE E170 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE FT3 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 183221, WITH AN EXPIRATION DATE OF JANUARY 2016. THE E411 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE FT3 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 183221, WITH AN EXPIRATION DATE OF JANUARY 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528292 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1