The investigation has determined that a non-reproducible, higher than expected, vitros tropi es result was obtained from a single patient sample when tested on a vitros eciq immunodiagnostic system.A definitive assignable cause could not be determined.Based on the historical trop ies quality control performance, a vitros tropi es reagent issue is not a likely contributing factor to this event.However, given the fact the level 1 control does not adequately evaluate performance of the vitros tropi es reagent for sample with troponin i concentrations < url (0.034 ng/ml), a reagent issue cannot be entirely ruled out as a contributing factor.An instrument related issue cannot be ruled out as a contributing factor as precision testing to evaluate vitros instrument performance was not performed.Pre analytical sample processing could not be ruled out as a contributing factor, as it was unknown if the customer was processing the samples in accordance with the sample collection device manufacturer¿s recommendations for sample centrifugation.It is likely that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
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The customer obtained a non-reproducible, higher than expected result from a single patient sample processed on a vitros eciq immunodiagnostic system using vitros tropi es reagent.Sample 1 result of 01.92 ng/ml versus the expected result of < 0.012 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected result was reported outside of the laboratory, however a corrected report was subsequently issued.No treatment was altered, initiated or stopped based on the reported result.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc., complaint numbers (b)(4).
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