The customer received a questionable free thyroxine (ft4) result for one patient sample from a cobas e602 analyzer.The specific date of testing was not provided.The sample was submitted for investigation and tested on a cobas 8000 e602, cobas e411 and a siemens centaur analyzer on (b)(6) 2015.Customer's result: 2.61 and 2.65 ng/ml.Centaur: 2.1 ng/ml.Cobas 8000 e602: 2.54 ng/ml.Cobas e411: 2.55 ng/ml.Information concerning which result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.With the information provided, a general reagent issue could be excluded.As insufficient sample volume was available, no further investigation could be performed.Differences in the results between methods could be due to the different setups of the assays, the antibodies used and the variances in reference methods.The results for all thyroid parameters vary with age and gender of the patient and other population characteristics.These factors should be taken into account when analyzing the results.
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