BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 3947534 · Received July 21, 2014

    Report

    Report Number
    1823260-2014-05389
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 28, 2014
    Report Date
    August 13, 2014
    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

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR FURTHER INVESTIGATION. THE CUSTOMER'S RESULTS WERE CONFIRMED. AN INTERFERING FACTOR AGAINST THE RUTHENIUM-LABELED DETECTION ANTIBODY OF BOTH FT3 AND FT4 ASSAYS WAS IDENTIFIED IN THE SAMPLE. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE. THE FOLLOWING FIELDS HAVE BEEN UPDATED: BRAND NAME; COMMON DEVICE NAME AND PRODUCT CODE; CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE; MANUFACTURING SITE; PMA/510(K) NUMBER. OTHER REAGENT(S) INVOLVED IN THE COMPLAINT: BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE CATALOG NUMBER: 06437281190, LOT NUMBER: 177593, EXPIRATION DATE: ASKU, MANUFACTURING SITE: SAME AS ENTERED ON PMA/510(K)#: K961489.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR FREE TRIIODOTHYRONINE (FT3) AND FREE THYROXINE (FT4). THE SAMPLE INITIALLY RESULTED AS 7.97 PMOL/L FOR FT3 AND 31.44 PMOL/L FOR FT4. IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER SITE FOR TESTING ON A CENTAUR ANALYZER ON (B)(4) 2014. THE CENTAUR ANALYZER RESULTS WERE 2.9 PG/ML FOR FT3 AND 1.02 NG/DL FOR FT4. THE VALUES FROM THE CENTAUR ANALYZER WERE WITHIN NORMAL RANGE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FT3 REAGENT LOT NUMBER WAS 177312 AND THE FT4 REAGENT LOT NUMBER WAS 177593. THE CUSTOMER WAS ASKED, BUT DID NOT PROVIDE THE FT3 AND FT4 REAGENT EXPIRATION DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424994 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 177312

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR