BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4850699 · Received June 17, 2015

    Report

    Report Number
    1823260-2015-03664
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    ASKU
    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 PATIENT SAMPLE FOR INVESTIGATION. DURING THE INVESTIGATION, ERRONEOUS FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E602 ANALYZER, A CENTAUR ANALYZER, AN E170 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 ATTACHMENT TO THE MEDWATCH FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E170 ANALYZER SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT3 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 183221 WITH AN EXPIRATION DATE OF 01/01/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S E602 ANALYZER IS NOT KNOWN. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394095 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1