The investigation has determined that higher than expected phenytoin (phyt) results were obtained from a single patient sample as well as a quality control fluid using vitros chemistry products phyt slides lot 2620-0173-7028 on two vitros 5600 integrated systems.The cause of the higher than expected qc results is unknown, but is likely related to improper fluid handling.The customer could not confirm that the qc was mixed properly on the days in question.Additionally, the customer dilutes their qc prior to running; per the instructions for use, there is no protocol for qc dilution.The most likely assignable cause for the higher than expected patient results is a sample related issue, likely due to improper pre-analytical sample handling protocol.The customer was not able to provide details on the sample appearance at the time of processing, however the sample showed elevated hemolysis that increased after the initial run of the sample on both systems.Per the phyt ifu, hemolyzed samples should not be used.The customer is not following the sample collection device manufacturer¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed by the customer.Based on historical quality control results, a vitros phyt lot 2620-0173-7028 performance issue is not a likely contributor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros phyt reagent lot 2620-0173-7028.Vitros phyt, vitros crmb, and vitros alkp within run precision testing was performed by the customer on both vitros 5600 integrated systems.The testing yielded results that were within acceptable guidelines, further indicating a reagent issue or an issue with the vitros 5600 integrated systems is unlikely.
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A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected phenytoin (phyt) results obtained from a single patient sample using vitros chemistry products phyt slides on two vitros 5600 integrated systems.(b)(4).Patient sample result of 24.3 ug/ml vs.An expected result of 7.6 ug/ml mas chemtrak-h l3 control lot chu21113a results of 30.56 and 32.12 vs expected result of 221.14 ug/ml.(b)(4).Patient sample result of 23.1 ug/ml vs.An expected result of 7.6 ug/ml mas chemtrak-h l3 control lot chu21113a results of 32.77, 32.98, 32.10 and 29.67 vs expected result of 221.14 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 non-reproducible, higher than expected vitros phyt results were reported from the laboratory and a corrected report was issued.No treatment was initiated, altered or stopped based upon the initial reported results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 3 of 8 mdr¿s for this event.Eight (8) 3500a forms are being submitted for this event as 8 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).
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