BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4 G4 ELECSYS COBAS E 200

    MDR report key: 15093412 · Received July 25, 2022

    Report

    Report Number
    1823260-2022-02177
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    April 8, 2016
    Report Date
    July 25, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 ASSAY RESULTS ON A COBAS 8000 - COBAS E 602 MODULE. THE PHYSICIAN STATES THAT THE FT4 RESULTS FOR ONE PATIENT HAVE NOT MATCHED THE CLINICAL PICTURE SINCE 2016. THE PROVIDED RESULTS ARE LISTED BELOW BY DATE. (B)(6) 2016: 3.68 NG/DL, (B)(6) 2016: 3.28 NG/DL, (B)(6) 2016: 4.25 NG/DL, (B)(6) 2018: 3.11 NG/DL, (B)(6) 2018: 2.52 NG/DL, (B)(6) 2019: 2.92 NG/DL, (B)(6) 2020: 3.29 NG/DL, (B)(6) 2021: 2.81 NG/DL, (B)(6) 2021: 3.30 NG/DL, THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547136 FT4 G4 ELECSYS COBAS E 200 RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS FT4 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female