BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 4871049 · Received June 26, 2015

    Report

    Report Number
    1823260-2015-03719
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A NEW SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION ON (B)(6) 2015. DURING THE INVESTIGATION, THE SAMPLE WAS TESTED ON A CENTAUR ANALYZER, RESULTING AS 5.0 UIU/ML FOR TSH, 0.7 NG/DL FOR FT4, AND 3.7 PG/ML FOR FT3.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NOT SUFFICIENT VOLUME OF THE PATIENT SAMPLE LEFT FOR FURTHER INVESTIGATIONS. THERE IS MOST LIKELY NO GENERAL REAGENT ISSUE. WHEN COMPARING VALUES GENERATED BY DIFFERENT TYPES OF ANALYZERS, VARIANCES CAN BE EXPECTED. FOR THYROID PARAMETERS, AGE, GENDER, AND OTHER CHARACTERISTICS ARE TO BE CONSIDERED WHEN ANALYZING THE MEASURED VALUES.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS GRAVES DISEASE. INVESTIGATIONS OF THE NEW PATIENT SAMPLE PROVIDED HAVE CONCLUDED THAT THERE WAS AN INTERFERING FACTOR TO STREPTAVIDIN PRESENT IN THE SAMPLE. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). THIS MEDWATCH WILL COVER FT3. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REFERRING TO FT4. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REFERRING TO TSH. A SAMPLE WAS INITIALLY TESTED AT ANOTHER SITE ON (B)(6) 2015. THE PATIENT WAS THEN TRANSFERRED TO THE CUSTOMER SITE. THE CUSTOMER SITE TESTED A SAMPLE FROM THE SAME PATIENT ON AN E602 ANALYZER ON (B)(6) 2015. IT WAS BELIEVED THAT THE SAMPLE FROM THE OTHER SITE TESTED ON (B)(6) 2015 AND THE SAMPLE TESTED AT THE CUSTOMER SITE ON (B)(6) 2015 WERE FROM DIFFERENT SAMPLE COLLECTIONS, BUT THIS COULD NOT BE CONFIRMED. THE RESULTS FROM THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE THAT WAS TESTED AT THE CUSTOMER SITE ON (B)(6) 2015 WAS PROVIDED FOR INVESTIGATIONS. DURING INVESTIGATIONS, THE PATIENT SAMPLE WAS TESTED ON AN E MODULE ANALYZER, AN E411 ANALYZER, AND A CENTAUR ANALYZER. REFER TO THE ATTACHMENT FOR THE SPECIFIC PATIENT RESULT VALUES. THE RESULTS FROM THE INVESTIGATION WILL BE REPORTED TO THE CUSTOMER. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE OTHER SITE USES AN ELECSYS ANALYZER. THE SPECIFIC ANALYZER MODEL AND SERIAL NUMBER WERE ASKED FOR, BUT COULD NOT BE PROVIDED. THE REAGENT LOT NUMBER AND EXPIRATION DATE USED AT THE OTHER SITE WERE ASKED FOR, BUT WERE NOT PROVIDED. THE E602 ANALYZER SERIAL NUMBER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE E MODULE ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL (B)(4). THE FT3 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 183221, WITH AN EXPIRATION DATE OF 01/31/2016. THE E411 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE FT3 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 180230, WITH AN EXPIRATION DATE OF 09/30/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416565 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1