BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 4843528 · Received June 15, 2015

    Report

    Report Number
    1823260-2015-03614
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 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).

    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 RESULTS WERE IDENTIFIED 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. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. 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 FT4 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE ON THE E 170 ANALYZER WAS 178388 WITH AN EXPIRATION DATE OF 06/30/2015. THE FT4 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE ON THE E411 ANALYZER WAS 181732 WITH AN EXPIRATION DATE OF 01/31/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S E602 ANALYZER IS NOT KNOWN. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE DATA, A GENERAL FT4 REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. WHEN COMPARING VALUES FROM DIFFERENT TYPES OF ANALYZERS, VARIANCES CAN BE EXPECTED. FOR THYROID PARAMETERS, AGE, GENDER AND OTHER PATIENT CHARACTERISTICS SHOULD BE CONSIDERED WHEN COMPARING VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387261 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1