BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7384600 · Received March 30, 2018

    Report

    Report Number
    1823260-2018-00963
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 30, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    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).(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E801 MODULE. THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATION WHERE DISCREPANT ELECSYS FT3 III (FT3 III) RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD AND A COBAS E801 MODULE USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S E801 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 232740 WITH AN EXPIRATION DATE OF JUL-2018. FROM THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228515 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1