BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 5191742 · Received October 30, 2015

    Report

    Report Number
    1823260-2015-04418
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    September 15, 2015
    Report Date
    December 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE PRESENCE OF A RUTHENIUM INTERFERING FACTOR. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE AVAILABLE DATA, A GENERAL CALIBRATION OR REAGENT ISSUE CAN BE EXCLUDED. QUALITY CONTROLS WERE ACCEPTABLE. A POSSIBLE ROOT CAUSE COULD BE AN INTERFERING FACTOR PRESENT IN THE PATIENT'S SAMPLE, BUT, THIS COULD NOT BE CONFIRMED AS THE SAMPLE WAS NOT AVAILABLE TO COMPLETE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS CLARIFIED TO BE (B)(6) 2015. IT WAS CLARIFIED THAT THE PATIENT RESULTS FROM 09/15/2015 WERE FROM A DIFFERENT SAMPLE. THE PATIENT RESULTS FROM (B)(6) 2015 WERE FROM THE SAME SAMPLE. CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE WERE UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4 II) AND FREE TRIIODOTHYRONINE (FT3). OF THE DATA PROVIDED, ERRONEOUS FT4 AND FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E601 ANALYZER AND AN ABBOTT ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN DID NOT TRUST THE RESULTS AS THEY DID NOT FIT THE PATIENT'S CLINICAL HISTORY. THE PHYSICIAN REQUESTED REPEAT TESTING ON A DIFFERENT SYSTEM. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II ERRONEOUS RESULTS. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. NO ADVERSE EVENT OCCURRED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722557 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 185694

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR