The customer reported that they received questionable results for one patient samples tested for thyrotropin (tsh), free triiodothyronine (ft3), and free thyroxine (ft4).It was determined that the sample had erroneous results for ft3 and ft4.The specific date of the event was asked for, but not provided.This medwatch will cover ft4.Refer to the medwatch with (b)(6) for information referring to ft3.The sample was initially tested at the customer site on an e602 analyzer.During investigations, the patient sample was tested on an e170 analyzer, an e411 analyzer, and a centaur analyzer.Refer to the attachment for the specific patient result values.It was asked, but it is unknown which patient results, if any, were reported outside of the laboratory.It was asked, but it is not known if the patient was adversely affected.No adverse events were alleged.The e602 analyzer serial number used at the customer site was asked for, but not provided.The e170 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 180539, with an expiration date of october 2015.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 184927, with an expiration date of march 2016.A specific root cause could not be determined based on the provided information.Further investigation was not possible as there was no remaining volume of the patient sample available.It is possible that there was sample handling issue when the ft4 results at the customer site were generated since there was a large difference in results when comparing results from the the customer's analyzer to results from like analyzers used for investigation.A general reagent issue could not be detected.Given the different setups of all assays, the antibodies used, and the variances in reference methods, differences in values may occur when comparing assay values from different vendors.For thyroid parameters, age, gender, and other characteristics are to be considered when analyzing measured values.
|