BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 6419240 · Received March 20, 2017

    Report

    Report Number
    1823260-2017-00589
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    November 2, 2016
    Report Date
    April 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS HAVE DETERMINED THAT THE SAMPLE CONTAINS AN INTERFERENT TO COMPONENTS USED IN THE FT3 AND FT4 ASSAYS. THIS LIMITATION IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). MEDWATCH FIELD FACILITY NAME - THE FULL FACILITY NAME WAS PROVIDED AS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED FOR THE ELECSYS FT3 III (FT3) AND THE ELECSYS FT4 II ASSAY (FT4) ON A COBAS 8000 E 602 MODULE. THE RESULTS WERE SAID THE BE OUTSIDE OF THE RESPECTIVE REFERENCE RANGES FOR THE ROCHE ASSAYS, BUT WERE NORMAL WHEN TESTED WITH THE SAME METHODS ON AN ABBOTT ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT DOES NOT HAVE ANY SYMPTOMS OF THYROID DISEASE. THIS MEDWATCH WILL COVER FT4 REAGENT LOT NUMBER 158223. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3 REAGENT LOT NUMBER 152267, REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3 REAGENT LOT NUMBER 179026, AND REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT4 REAGENT LOT NUMBER 180429. PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE FROM (B)(6) 2016 WAS TESTED WITH FT3 REAGENT LOT 152267 AND FT4 REAGENT LOT 158223. THE SAMPLE FROM (B)(6) 2017 WAS TESTED WITH FT3 REAGENT LOT 179026 AND FT4 REAGENT LOT 180429. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E602 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199870 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 158223

    Patients

    Seq Age Sex Outcome Treatment
    1 APDIRA| LANTUS