BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7818067 · Received August 27, 2018

    Report

    Report Number
    1823260-2018-02866
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 7, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    04015630939718
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NOT ENOUGH SAMPLE MATERIAL REMAINING TO COMPLETE THE INVESTIGATION. BASED ON THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED THYROID RESULTS FOR 6 PATIENT SAMPLES TESTED ON A COBAS E801 MODULE. THE CUSTOMER PROVIDED THE PATIENT SAMPLES FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT3 III (FT3 III), TSH AND FT4 BETWEEN THE CUSTOMER'S E801 MODULE, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE, A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE AND THE SIEMENS CENTAUR METHOD. IT IS NOT KNOWN IF THE INITIAL RESULTS FROM THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. 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 277945 WITH AN EXPIRATION DATE OF 30-SEP-2018. THE FT3 III REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 314824 WITH AN EXPIRATION DATE OF 31-MAY-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656963 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU 04015630939718

    Patients

    Seq Age Sex Outcome Treatment
    1