BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 2132639 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03317
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLE RESULTS FOR FREE T4 (FT4) ON THEIR MODULAR ANALYTICS E-MODULE (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR TWO SAMPLES WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RECEIVED A THYROID PANEL WITH INCONGRUOUS RESULTS AND REPEATED THE FT4 TESTS. REPEAT TESTING WAS PERFORMED ON THE SAME E-MODULE AND ISSUED AS A CORRECTED REPORT. THE FIRST PATIENT'S INITIAL FT4 RESULT WAS 7.01 NG/DL. THE REPEAT RESULT WAS 1.58 NG/DL. THE SECOND PATIENT'S INITIAL FT4 RESULT WAS 6.47 NG/DL. THE REPEAT RESULT WAS 1.11 NG/DL. THE CUSTOMER WAS NOT AWARE OF ANY ADVERSE AFFECTS TO THE PATIENTS AS A RESULT OF THIS EVENT. THE CUSTOMER REFUSED A SERVICE VISIT. THE CUSTOMER RESOLVED THE ISSUE BY TROUBLESHOOTING THE ANALYZER. THEY PERFORMED LIQUID FLOW CLEANING THREE TIMES AND MEASURING CELL PREPARATION TWENTY TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 16145501

    Patients

    Seq Age Sex Outcome Treatment
    1