The initial reporter stated that they received discrepant results for one patient sample tested with d-di tina-quant d-dimer gen.2 on a cobas t 511 coagulation analyzer.No incorrect values were reported outside of the laboratory.The cobas t 511 coagulation analyzer is not released for distribution in the united states, nor is it like or similar to a product released for distribution in the united states.The sample initially resulted with a d-dimer value of 19.2 ug/ml when tested on the t 511 analyzer.The sample was repeated on the t 511 analyzer, resulting with a value of 19.1 ug/ml.The sample was repeated a second time on the t 511 analyzer, resulting with a value of > 9.46 ug/ml accompanied by a data flag.The sample was repeated a third time of the t 511 analyzer at a reduced sample volume, resulting with a value of 19.1 ug/ml.The same sample was also tested twice on a cobas t 411 coagulation analyzer, resulting with values of 5.41 ug/ml and 5.30 ug/ml.No adverse events were alleged to have occurred with the patient.The serial number of the t 511 analyzer is (b)(4).
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