BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 5015325 · Received August 19, 2015

    Report

    Report Number
    1823260-2015-03991
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    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

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. DURING INVESTIGATION THE CUSTOMER'S FT4 RESULTS WERE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 3 PATIENT SAMPLES TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER PROVIDED DATA FOR THE 3 PATIENT SAMPLES FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS TSH, FT4 AND FT3 RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE BETWEEN THE CUSTOMER'S E602 ANALYZER, A CENTAUR ANALYZER, AN E 170 ANALYZER USED AT THE INVESTIGATION SITE AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. THE DATE OF TESTS PERFORMED AT THE CUSTOMER SITE IS NOT KNOWN. ALL RESULTS FROM THE INVESTIGATION WILL BE REPORTED TO THE CUSTOMER. THIS MEDWATCH WILL COVER FT4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E 170 ANALYZER SERIAL NUMBER WAS 1519-01. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT4 REAGENT LOT NUMBER USED WITH THE E170 ANALYZER AT THE INVESTIGATION SITE WAS 180539 WITH AN EXPIRATION DATE OF 10/31/2015. THE FT4 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER AT THE INVESTIGATION SITE WAS 183473 WITH AN EXPIRATION DATE OF 01/31/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S E602 ANALYZER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547342 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1