BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4952539 · Received July 30, 2015

    Report

    Report Number
    1823260-2015-03883
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 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

    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 FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E602 ANALYZER, A CENTAUR ANALYZER, AN E602 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. NO ADVERSE EVENT WAS REPORTED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT3 REAGENT LOT NUMBER USED WITH THE E602 ANALYZER AT THE INVESTIGATION SITE WAS 183221 WITH AN EXPIRATION DATE OF 01/31/2016. THE FT3 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 180230 WITH AN EXPIRATION DATE OF 09/30/2015. 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 REAGENT ISSUE COULD BE EXCLUDED. THERE WAS NOT ENOUGH SAMPLE VOLUME LEFT TO COMPLETE THE INVESTIGATION. 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
    496235 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1