BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 6419150 · Received March 20, 2017

    Report

    Report Number
    1823260-2017-00592
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    January 31, 2017
    Report Date
    April 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE 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). UNIQUE IDENTIFIER (UDI)#: (B)(4). FACILITY NAME - THE FULL FACILITY NAME WAS PROVIDED AS "(B)(6)".

    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 FT3 REAGENT LOT NUMBER 179026. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3 REAGENT LOT NUMBER 152267, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT4 REAGENT LOT NUMBER 158223, AND REFER TO THE MEDWATCH WITH 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
    201041 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 179026

    Patients

    Seq Age Sex Outcome Treatment
    1 APDIRA| LANTUS