BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT4 III ASSAY

    MDR report key: 11176696 · Received January 15, 2021

    Report

    Report Number
    1823260-2021-00188
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 23, 2020
    Report Date
    March 22, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K131244
    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

    ON (B)(6) 2021, THE PATIENT'S SAMPLE WAS SENT FOR AN INVESTIGATION AND TESTED ON A COBAS 8000 E 801 MODULE. THE PATIENT'S ELECSYS TSH ASSAY RESULTS WERE "0.00500" UIU/ML AND "0.00500" UIU/ML. THE PATIENT'S ELECSYS FT4 III ASSAY RESULT WAS 2.16 NG/DL. THE PATIENT'S ELECSYS FT3 III RESULT WAS 3.80 PG/ML. THE CUSTOMER'S CALIBRATION DATA, QC DATA, AND SAMPLE PRE-ANALYTIC DETAILS WERE REQUESTED BUT NOT PROVIDED. THE OBSERVED DIFFERENCES IN FT4 VALUES GENERATED WITH THE ROCHE ASSAY AND ABBOTT ARCHITECT ASSAY ARE MOST LIKELY CAUSED BY DIFFERENCES IN THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED. BASED ON THE AVAILABLE INFORMATION, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING. NA.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER 1634-07. THE PATIENT'S INITIAL FT4 RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE FT4 RESULT AND ASKED FOR THE SAMPLE TO BE FURTHER INVESTIGATED. THE CUSTOMER PERFORMED REPEAT TESTING ON AN ABBOTT ARCHITECT ANALYZER FOR CONFIRMATION. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74376 ELECSYS FT4 III ASSAY RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS FT4 G3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1