BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 2102512 · Received May 25, 2011

    Report

    Report Number
    1823260-2011-02799
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 8, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF RESPONSE: IT IS UNKNOWN IF THE INITIAL REPORTER SENT A RESPONSE TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6). ANOTHER ASSAY RELATED TO THIS EVENT IS REPORTED IN THE MEDWATCH REPORT WITH (B)(6).

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE ELECSYS FREE T4 VALUE WAS VERIFIED WHEN TESTED ON A SIEMENS CENTAUR ANALYZER. INTERFERENCE ANALYSIS WAS ALSO PERFORMED. NO INTERFERING FACTOR WAS IDENTIFIED. NO ISSUE WITH THE ELECSYS FREE T4 REAGENT WAS VERIFIED. THE INVESTIGATION CONCLUDED THE FREE T4 RESULT IS THE TRUE VALUE AND THE ELECSYS RESULT SHOULD BE RELIABLE. NO FURTHER PATIENT DATA WAS PROVIDED, THEREFORE, THE CLINICAL PICTURE OF THE PATIENT COULD NOT BE CONCLUDED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED REGARDING THIS EVENT. THE DATE RECEIVED BY MANUFACTURER WAS (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE FREE T4 RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A MODULAR E MODULE, (B)(4). THE SAMPLE WAS INITIALLY TESTED TWICE AND RECOVERED 30 PMOL/L BOTH TIMES. THIS FREE T4 VALUE DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT OR THE PATIENT'S OTHER RESULTS. THE SAMPLE WAS REPEATED ON A BECKMAN ANALYZER AND RECOVERED 9.8 PMOL/L. THE PATIENT "POSSIBLY RECEIVED WRONG MEDICINE" DUE TO THE DISCREPANT RESULT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 00160863

    Patients

    Seq Age Sex Outcome Treatment
    1 005 YR