BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 8168553 · Received December 17, 2018

    Report

    Report Number
    1823260-2018-04904
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 28, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE SAMPLE WAS FOUND TO CONTAIN AN IMMUNOGLOBULIN THAT REACTS WITH THE REAGENT AND AFFECTS THE SAMPLE RESULTS. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM COBAS E 801 MODULE 1611-01. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER. THE INITIAL ELECSYS FT4 II ASSAY RESULT WAS 28.1 PMOL/L AND REPEAT RESULT WAS 16.1 PMOL/L. THE INITIAL ELECSYS TSH ASSAY RESULT WAS 1.28 MIU/L AND THE REPEAT RESULT WAS 2.56 MIU/L. THE INITIAL ELECSYS FT3 RESULT WAS 12.2 PMOL/L AND THE REPEAT RESULT WAS 4.7 PMOL/L. THIS MEDWATCH IS FOR THE FT3 ASSAY. REFER TO THE "MEDWATCHS" WITH PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER ASSAYS INVOLVED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007903 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR PROPANOLOL| VALIUM| ZYPREXA