BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 6610682 · Received June 5, 2017

    Report

    Report Number
    1823260-2017-01141
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    January 20, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. FROM THE INFORMATION, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. BASED ON THE DATA PROVIDED, IT WAS POSSIBLE THAT SAMPLES 3288222, 3885058, AND 821762 CONTAIN AN INTERFERING FACTOR THAT SPECIFICALLY INTERACTS WITH ONE OF THE IMMUNOLOGICAL COMPONENTS OF THE ASSAY. THE DIFFERENT EFFECTS RELATE TO THE SPECIFIC PHYSICAL REACTION CONDITIONS OF THE DIFFERENT MODULES/ANALYZERS USED FOR TESTING. AS NO SAMPLE MATERIAL REMAINED FOR FURTHER INVESTIGATION, THIS COULD NOT BE CONFIRMED. IT IS KNOWN THAT FUROSEMIDE AND LEVOTHYROXIN DO NOT INTERFERE WITH THE ASSAY. DIFFERENCES IN THE RESULTS FROM THE DIFFERENT MANUFACTURERS CAN VARY DEPENDING ON DIFFERENT SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND DIFFERENCES IN THE STANDARDIZATION MATERIALS AND METHODOLOGIES USED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RECEIVING HIGH ELECSYS FT4 II ASSAY RESULTS FOR MULTIPLE PATIENTS WITH NORMAL VALUES FOR THE ELECSYS TSH ASSAY. THE CUSTOMER REPEATED THE SAMPLES ON DIFFERENT ANALYZERS INCLUDING A COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4), A COBAS 8000 E 801 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER ALSO TESTED THE SAMPLES WITH DIFFERENT METHODS INCLUDING "SCANBODY TUBES", SCANTIBODY REAGENT (HBT HETEROPHILIC BLOCKING TUBE), AND PEG. DATA WAS PROVIDED FOR 26 PATIENT SAMPLES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE RESULTS WERE REPORTED TO MEDICAL PERSONNEL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SUSPECTED INTERFERENCE IN THE SAMPLES DUE TO RUTHENIUM OR STREPTAVIDIN OR DUE TO LEVOTHYROXINE AND FUROSEMIDE MEDICATIONS TAKEN BY THE PATIENT. THE CALIBRATION AND QC WERE ACCEPTABLE. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393599 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 225150

    Patients

    Seq Age Sex Outcome Treatment
    1