BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 3637122 · Received February 20, 2014

    Report

    Report Number
    1823260-2014-01170
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    February 3, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED TWO PATIENT SAMPLE TUBES FOR INVESTIGATION. AN INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED IN THE SAMPLE FOR FT3 AND FT4. THIS INTERFERENCE IS DOCUMENTED IN THE PACKAGE INSERT. OTHER REAGENT INVOLVED IN THIS EVENT: BRAND NAME: FT3 - FREE TRIIODOTHYRONINE COMMON DEVICE NAME: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE MANUFACTURER INFORMATION: SAME AS FOR TSH, THYROTROPIN CATALOG NUMBER: ASKU, LOT NUMBER: ASKU. EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TSH, THYROTROPIN. PMA/510(K)#: K963127.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPECIFIC PART NUMBER INVOLVED IN THE EVENT WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH), FREE THYROXINE (FT4), AND FREE TRIIODOTHYRONINE (FT3) RESULTS FOR ONE PATIENT ON THEIR E602 ANALYZER. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE PHYSICIAN QUESTIONED THE PATIENT'S THYROID RESULTS. A PEG PRECIPITATION WAS CONDUCTED BY THE CUSTOMER AND IT WAS SUSPECTED THE FT3 AND FT4 WERE AFFECTED BY A NON-SPECIFIC REACTION. THE CUSTOMER RETURNED THE PATIENT'S SAMPLE FOR INVESTIGATION. THE PATIENT'S SAMPLE WAS SENT FOR TESTING USING A CENTAUR ANALYZER. THE PATIENT'S TSH RESULT FROM THE E602 ANALYZER WAS 0.460 UIU/ML. THE RESULT FROM THE CENTAUR ANALYZER WAS 0.80 MIU/ML. THE PATIENT'S FT4 RESULT FROM THE E602 ANALYZER WAS 2.3 NG/DL. THE RESULT FROM THE CENTAUR ANALYZER WAS 1.4 NG/DL. THE PATIENT'S FT3 RESULT FROM THE E602 ANALYZER WAS 5.4 PG/ML. THE RESULT FROM THE CENTAUR ANALYZER WAS 2.2 PG/ML. THE CENTAUR RESULTS WERE REPORTED TO THE LABORATORY TECHNICIAN. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. THE CUSTOMER WOULD NOT PROVIDE INFORMATION ON WHETHER THE PATIENT WAS HARMED BY THIS EVENT. THE TSH, FT4, AND FT3 REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER WOULD NOT PROVIDE THE SPECIFIC DATE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107361 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1