BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 17604103 · Received August 23, 2023

    Report

    Report Number
    1823260-2023-02748
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    July 25, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    07613336171578
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. IT WAS DETERMINED THAT THE PATIENT SAMPLE CONTAINED AN INTERFERENCE AGAINST THE ANTIBODY/IDIOTYPE COMPONENT OF THE FT3 REAGENT. PER PRODUCT LABELING, "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." NO PRODUCT PROBLEM WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE FIRST E801 ANALYZER SERIAL NUMBER IS 1824-08. THE SERIAL NUMBER OF THE SECOND E801 ANALYZER WAS NOT PROVIDED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 ANALYTICAL UNITS COMPARED TO AN ABBOTT ANALYZER. ON (B)(6) 2023, THE RESULT FROM THE FIRST E801 ANALYZER WAS 9.36 PMOL/L. ON (B)(6) 2023, THE SAMPLE WAS TESTED ON THE SECOND E801 ANALYZER AND THE RESULT WAS 9.18 PMOL/L. ON (B)(6) 2023, THE RESULT FROM THE ABBOTT ARCHITECT WAS 3.95 PMOL/L. THE REFERENCE RANGES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138173 ELECSYS FT3 III TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS 668112 07613336171578

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male