A customer obtained higher than expected vitros phenytoin (phyt) results from vitros therapeutic drug monitoring performance verifiers (tdm pv) processed using vitros chemistry products phyt slides on two vitros 4600 chemistry systems.Analyzer (b)(4):
tdmpvi lot r7687 results of 12.1, 10.3, 11.1, 10.5, 10.5, 10.9, 11.0, 11.2 and 11.7 ug/ml vs the expected result of 8.3 ug/ml
tdm pvii lot t7688 results of 18.0, 17.6, 16.9, 17.3, 17.5, 18.0, 25.1, 19.4, 19.1, 18.2, 17.8, 17.1, 17.7, 17.4, 16.9, 16.8, 16.8, 17.3, 22.1, 23.2, 27.1, 23.4, 22.1, 17.9, 28.6, 25.3, 19.2, 19.9, 20.2, 17.0, 17.3 and 17.4 ug/ml vs the expected result of 14.0 ug/ml
analyzer (b)(4):
tdm pvii lot t7688 result of 17.3 ug/ml vs the expected result of 14.0 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 customer, through the distributor field engineer, indicated that patient results were reported outside of the laboratory while running vitros phyt during the timeframe of the event.However, the results were not questioned by a physician and no repeats were requested for any of the samples.It cannot be confirmed that patient results would not be affected if the issue were to recur undetected.There is no allegation of patient harm as a result of this event.This report is number 39 of 42 mdr¿s for this event.Forty-two (42) 3500a forms are being submitted for this event as 42 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).
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