The initial reporter stated they received unexpected high results for two samples from the same patient tested with the elecsys testosterone ii assay on a cobas e 411 immunoassay analyzer.The sample measurements were reported outside of the laboratory and did not agree with the patient's clinical history, other test results, and imaging results.On (b)(6) 2018, a first sample from the patient was tested on the e411 analyzer, resulting with a testosterone value of > 52.1 nmol/l.On (b)(6) 2020, a second sample from the patient was tested on the e411 analyzer, resulting with a testosterone value of > 52.0 nmol/l.This sample was sent to another site for testing on a beckman coulter dxi800 analyzer, resulting with a testosterone value of 26.11 nmol/l (reference range = 8.40 - 28.70 nmol/l) on (b)(6) 2020.The serial number of the e411 analyzer is (b)(4).
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