BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7566351 · Received June 4, 2018

    Report

    Report Number
    1823260-2018-01722
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 12, 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 REVIEW IT WAS FOUND THAT THE ELECSYS FT4 II ASSAY (FT4 II) RESULTS PROVIDED WERE ALSO A REPORTABLE MALFUNCTION ONCE THE CENTAUR DATA WAS MADE AVAILABLE. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION OF THE FT4 II RESULTS. (B)(6).

    Additional Manufacturer Narrative · 0

    A SAMPLE FROM THE PATIENT WAS RECEIVED FOR FURTHER INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE FT3 III REAGENT WAS CONFIRMED. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING. PRODUCT LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE OBSERVED MATHEMATICAL DIFFERENCES OF THE TSH AND FT4 II VALUES BETWEEN THE TWO DIFFERENT ANALYZERS RELATES TO THE DIFFERENCES OF THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED IN: (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 801 MODULE. OF THE DATA PROVIDED, THE ELECSYS TSH ASSAY (TSH) AND THE ELECSYS FT3 III (FT3 III) RESULTS WERE A REPORTABLE MALFUNCTION. THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATION AND IT WAS TESTED ON A COBAS E602 MODULE, A COBAS E 411 IMMUNOASSAY ANALYZER, AND A COBAS 8000 E 801 MODULE AT THE INVESTIGATION SITE. THE CUSTOMER ALSO HAD THE PATIENT SAMPLE TESTED ON A CENTAUR. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH. DISCREPANT RESULTS ARE HIGHLIGHTED. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE E602 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WITH THE E602 MODULE WAS 242379 WITH AN EXPIRATION DATE OF 31-OCT-2018. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WITH THE E411 ANALYZER WAS 257857 WITH AN EXPIRATION DATE OF 31-JUL-2018. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WITH THE E801 WAS 277939 WITH AN EXPIRATION DATE OF 31-DEC-2018. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407097 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1