BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7818149 · Received August 27, 2018

    Report

    Report Number
    1823260-2018-02872
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 14, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    04015630939718
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 8 PATIENT SAMPLES TESTED FOR MULTIPLE THYROID ASSAYS ON THE COBAS 8000 E 801 MODULE . OF THESE SAMPLES, ONE HAD ERRONEOUS RESULTS FOR ELECSYS FT3 III. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A SECOND E 801 ANALYZER, A COBAS 8000 E 602 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLES WERE ALSO TESTED ON A CENTAUR ANALYZER. IN ADDITION, THE SAMPLES WERE TREATED WITH POLYETHYLENE GLYCOL (PEG) AND TESTED ON A ROCHE ELECSYS ANALYZER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 801 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION WAS (B)(4). FT3 REAGENT LOT NUMBER 314824, WITH AN EXPIRATION DATE OF 31-MAY-2019 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 602 ANALYZER USED FOR INVESTIGATION WAS (B)(4). FT3 REAGENT LOT NUMBER 242379, WITH AN EXPIRATION DATE OF 31-OCT-2018 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 411 ANALYZER USED FOR INVESTIGATION WAS (B)(4). FT3 REAGENT LOT NUMBER 277945, WITH AN EXPIRATION DATE OF 30-SEP-2018 WAS USED ON THIS ANALYZER. THE VALUES GENERATED ON THE ROCHE SYSTEMS ARE SIMILAR TO THOSE GENERATED ON THE SIEMENS CENTAUR. THE DIFFERENCES IN RESULTS ARE RELATED TO THE DIFFERENCES IN THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED. THE NORMAL REFERENCE RANGES USED BY DIFFERENT ASSAY VENDORS CAN EQUALLY BE DIFFERENT. THIS RELATES TO THE POPULATION USED AND THE CALCULATION MODE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659191 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU 04015630939718

    Patients

    Seq Age Sex Outcome Treatment
    1