BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7566345 · Received June 4, 2018

    Report

    Report Number
    1823260-2018-01725
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 10, 2018
    Report Date
    June 13, 2018
    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 · 0

    UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS CAUSED THE HIGH FT4 II AND FT3 III RESULTS. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 II (FT4 II), ELECSYS FT3 III (FT3 III) AND ELECSYS TSH (TSH) ON A COBAS E 801 MODULE. THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT4 II, FT3 III AND TSH BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT3 III. (B)(4). REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE PATIENT SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING. REFER TO ATTACHED DATA FOR THESE RESULTS. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT NUMBER USED WITH THE E602 MODULE WAS 242379 WITH AN EXPIRATION DATE OF 31-OCT-2018. THE FT3 III REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 257857 WITH AN EXPIRATION DATE OF 31-JUL-2018. THE FT3 III REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 277939 WITH AN EXPIRATION DATE OF 31-DEC-2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408262 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1