BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 3971432 · Received July 31, 2014

    Report

    Report Number
    1823260-2014-05765
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 20, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ASKED, BUT COULD NOT CONFIRM IF THE PROVIDED SAMPLES WERE FROM THE SAME PATIENT INVOLVED IN THE EVENT OR A DIFFERENT PATIENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION PROVIDED. A CORRELATION COULD NOT BE MADE BETWEEN THE SAMPLES PROVIDED FOR INVESTIGATION AND THE ORIGINAL COMPLAINED PATIENT SAMPLES. THE CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION FOR INVESTIGATIONS, BUT HAVE REFUSED TO PROVIDE THIS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). REFERENCE THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DATA RELATED TO FT3. REFERENCE THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DATA RELATED TO FT4.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER, THEY PROVIDED THE WRONG SAMPLE ALIQUOTS FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY NOTICED DISCREPANCIES IN THE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ROCHE THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4) ASSAYS WHEN COMPARED TO THE SAME ASSAYS ON OTHER MANUFACTURER INSTRUMENTS. THE CUSTOMER STATED THAT RESULTS FROM THE ROCHE FT3 AND FT4 ASSAYS RECOVER SIGNIFICANTLY HIGHER WHEN COMPARED TO RESULTS FROM ABBOTT ARCHITECT AND SIEMENS CENTAUR ANALYZERS AT ANOTHER SITE. LOWER RECOVERY WAS SEEN IN THE ROCHE TSH ASSAY, ALTHOUGH THE CUSTOMER BELIEVED THAT THIS TEST CORRELATED WELL BETWEEN ALL THREE ANALYZERS. THIS MEDWATCH WILL COVER THE TSH ASSAY. A SAMPLE FROM PATIENT ONE INITIALLY RESULTED AS 8.45 PMOL/L FOR FT3, 34.86 PMOL/L FOR FT4, AND 2.73 MIU/L FOR TSH. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER AND RESULTED AS 4 PMOL/L FOR FT3, 16 PMOL/L FOR FT4, AND 10.1 MIU/L FOR TSH. THE SAMPLE WAS ALSO REPEATED ON A SIEMENS CENTAUR ANALYZER AND RESULTED AS 4 PMOL/L FOR FT3, 18 PMOL/L FOR FT4, AND 12.5 MIU/L FOR TSH. IT WAS NOTED THAT THIS PATIENT WAS ON T4, BUT WHEN THE PATIENT WAS PLACED ON CARBIMAZOLE, THE DOCTOR NOTICED THAT THE FT3 AND FT4 STARTED TO ELEVATE. A SAMPLE FROM PATIENT TWO, A FEMALE BORN ON (B)(6) 1989, INITIALLY RESULTED AS 25.77 PMOL/L FOR FT3, 98.06 PMOL/L FOR FT4, AND 0.768 MIU/L FOR TSH ON (B)(6) 2014. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER AND RESULTED AS 4.7 PMOL/L FOR FT3, 13 PMOL/L FOR FT4, AND 2.1 MIU/L FOR TSH. THE SAMPLE WAS ALSO REPEATED ON A SIEMENS CENTAUR ANALYZER AND RESULTED AS 4.8 PMOL/L FOR FT3, 14 PMOL/L FOR FT4, AND 2.2 MIU/L FOR TSH. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE INITIAL TSH VALUES WERE TESTED ON AN E602 ANALYZER SERIAL NUMBER (B)(4). THE PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION AND INVESTIGATIONS HAVE DETERMINED THAT THE CUSTOMER'S HIGH FT3 AND FT4 PATIENT RESULTS COULD BE REPRODUCED. PATIENT RESULTS FOR OLDER GENERATION FT3 AND FT4 TESTS ON THE E602 WERE FOUND WITHIN THE REFERENCE RANGES. A PREWASH EFFECT COULD BE OBSERVED. THE DIFFERENCE BETWEEN THE RESULTS MAY INDICATE AN INTERFERING FACTOR TO STREPTAVIDIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447095 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 177538

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR T4 (PATIENT ONE)| CARBIMAZOLE (PATIENT ONE)