BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 8068880 · Received November 14, 2018

    Report

    Report Number
    1823260-2018-04269
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    September 28, 2018
    Report Date
    November 14, 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 · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER, WHO USES THE ABBOTT ARCHITECT METHOD, QUESTIONED FT4 RESULTS AND SENT 3 SAMPLES FROM 1 PATIENT TO ANOTHER LABORATORY USING THE COBAS E801 MODULE FOR TESTING. BASED ON THE DATA PROVIDED, DISCREPANT RESULTS FOR ALL 3 SAMPLES WERE GENERATED BETWEEN THE ABBOTT METHOD AND THE E801 MODULE USING THE ELECSYS FT4 III (FT4 III) ASSAY. THE CUSTOMER SUBMITTED 2 NEW SAMPLES OBTAINED THE SAME DAY FROM THE PATIENT FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT4 III AND ELECSYS FT3 III (FT3 III) BETWEEN THE CENTAUR METHOD AND AN E801 MODULE USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE USED BY THE CUSTOMER WAS 1634-07. THE E801 MODULE USED AT THE INVESTIGATION SITE WAS 14D9-06. CALIBRATION AND QC DATA AT THE INVESTIGATION SITE WAS ACCEPTABLE. BASED ON THE DATA PROVIDED, THE FT4 III AND FT3 III RESULTS FROM ALL METHODS WERE ABOVE THE NORMAL REFERENCE RANGES FOR EACH RESPECTIVE ASSAY. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS, IN THIS CASE SIEMENS, CAN GENERATE DIFFERENT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911645 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 314824 04015630939718

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR