BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 5625066 · Received May 3, 2016

    Report

    Report Number
    1823260-2016-00569
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 9, 2016
    Report Date
    May 9, 2016
    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

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO REMAINING VOLUME OF THE PATIENT SAMPLE AVAILABLE FOR FURTHER INVESTIGATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR FREE TRIIODOTHYRONINE (FT3) AND FREE THYROXINE (FT4) ON AN E602 ANALYZER. THIS MEDWATCH WILL COVER FT4. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3. THE SAMPLE WAS INITIALLY TESTED AT THE CUSTOMER SITE ON AN E602 ANALYZER AND THESE INITIAL FT3 AND FT4 RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED FOR FT3 AND FT4 ON AN E170 ANALYZER ON (B)(6) 2016 AND AN E411 ANALYZER ON (B)(6) 2016. REFER TO THE ATTACHMENT FOR THE RESULT DATA. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE E602 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE E170 ANALYZER USED FOR INVESTIGATION PURPOSES WAS 1519-01. FT4 REAGENT LOT NUMBER 188609, WITH AN EXPIRATION DATE OF OCTOBER 2016 WAS USED ON THIS ANALYZER. THE E411 ANALYZER USED FOR INVESTIGATION PURPOSES WAS 0600-12. FT4 REAGENT LOT NUMBER 188609, WITH AN EXPIRATION DATE OF OCTOBER 2016 WAS USED ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282142 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1