BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS T3

    MDR report key: 9280977 · Received November 5, 2019

    Report

    Report Number
    1823260-2019-03981
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 5, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K962508
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL T3 RESULTS FOR THE SAMPLES WERE PROVIDED. PATIENT ID (B)(6): COBAS E801=344 NG/DL, COBAS E601=177.9 NG/DL. PATIENT ID (B)(6): COBAS E801=605 NG/DL, COBAS E601=248 NG/DL. PATIENT ID (B)(6): COBAS E801=407 NG/DL, COBAS E601=184.3 NG/DL. SAMPLES FROM THE PATIENTS WERE SUBMITTED FOR INVESTIGATION. INITIAL INVESTIGATION OF THE SAMPLES CONFIRMED THEY CONTAINED AN IMMUNOGLOBULIN THAT REACTS WITH THE REAGENT AND AFFECTS THE SAMPLE RESULTS. FURTHER TESTING FOUND AN INTERFERING FACTOR AGAINST STREPTAVIDIN COULD BE IDENTIFIED IN THE SAMPLE FOR PATIENT ID (B)(6). THESE INTERFERENCES ARE DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY AS "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."

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS T3 RESULTS FOR 4 PATIENTS TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO A COBAS 6000 E 601 MODULE. FROM THE DATA PROVIDED, 3 PATIENTS HAD QUESTIONABLE RESULTS. THE COBAS E601 RESULTS WERE DEEMED CORRECT. THE CUSTOMER STATED THAT FOR ONE UNSPECIFIED PATIENT, THE DATA WAS REPORTED OUTSIDE OF THE LABORATORY BUT A CORRECTED REPORT WAS ISSUED. THE CUSTOMER ONLY PROVIDED THE SERIAL NUMBER FOR 1 COBAS E801, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074244 ELECSYS T3 RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 40680200

    Patients

    Seq Age Sex Outcome Treatment
    1