BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4996702 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03945
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    May 18, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DIFFERENCE IN THE RESULTS FOR TWO METHODOLOGIES COULD BE DUE TO THE DIFFERENT SETUPS OF ALL ASSAYS, THE ANTIBODIES USED, AND THE VARIANCES IN THE REFERENCE METHODS. DIFFERENCES IN RESULTS MAY OCCUR WHEN COMPARING ASSAYS FROM DIFFERENT MANUFACTURERS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE FROM A MODULAR ANALYZER AND SUSPECTED INTERFERENCE WITH VOLTAREN (DICLOFENAC SODIUM). REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FREE TRIIODOTHYRONINE (FT3) ASSAY. THE INITIAL RESULTS WERE: THYROTROPIN (TSH): 0.8 UIU/ML, FREE TRIIODOTHYRONINE (FT3): 4.8 NG/DL, FREE THYROXINE (FT4): 1.1 PG/ML. THE SAMPLE WAS RETESTED ON A CENTAUR ANALYZER AND THE RESULTS WERE: TSH: 0.6 UIU/ML, FT3: 1.9 NG/DL, FT4: 1.1 PG/ML. AFTER PEG TREATMENT, THE FT3 RESULT WAS 7.6 NG/DL. INFORMATION CONCERNING IF ANY RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528324 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR