A customer obtained both higher and lower than expected results on multiple quality control (qc) fluid samples after calibrating vitros chemistry products phenytoin (phyt) slides using a vitros 4600 chemistry system.The customer also reported higher than expected qc results after calibrating vitros chemistry products carbamazepine (crbm) slides using a vitros 4600 chemistry system.Vitros chemistry products phyt slides, lot 2617-0167-1487: control fluid results of 12.3, 12.5, 11.6, 12.2, 12.4, 12.2, 13.0, 11.7, 10.5, 11.1 and 11.1 ug/ml were obtained with an expected serum result of 7.6 ug/ml.Control fluid results of 30.4, 32.9, 24.8, 31.4, 30.7, 31.1, 33.4, 28.9, 23.6, 25.6, 22.7 and 11.9 ug/ml were obtained with an expected serum result of 15.1 ug/ml.Control fluid results of 40.0, 39.8, 36.7, 33.6, 40.0, 40.0 and 38.2 ug/ml were obtained with an expected serum result of 24.3 ug/ml.Vitros chemistry products crbm slides, lot 3939-0100-5621.Control fluid results of 17.1, 17.2, 17.3, 17.5, 17.2, 17.4, 16.9, 16.8, 17.0, 17.1, 17.7, 18.2 and 17.4 ug/ml were obtained with an expected serum result of 12.89 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The vitros phyt and crbm results were generated from non-patient fluids and no results were reported outside the lab.There was no allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).
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