The investigation confirmed that non-reproducible, higher than expected vitros trop i es results were obtained from two patient samples processed on the vitros eciq immunodiagnostic system.The investigation could not determine a definitive assignable cause.Pre-service within-run vitros tropi es precision testing was not performed, therefore, an instrument related issue cannot be ruled out as contributing to the event.An ortho field engineer replaced the incubator shuttle and all adjustments.In addition, the wash station and tubing were replaced due to wear.Acceptable tropi es performance was obtained after service, however, it is unknown if the service actions taken mitigated an instrument issue that may have contributed to the event.Based on historical quality control results, a vitros tropi es reagent related issue is not a likely contributor to the event.However, the l1 control does not adequately evaluate performance of the vitros tropi es reagent for sample with troponin i concentrations < url (0.034 ng/ml), therefore, a reagent issue cannot be entirely ruled out as a contributing factor.Furthermore, pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer was following the sample collection device manufacture¿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.
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The customer observed non-reproducible, higher than expected, vitros tropi es results were obtained from two patient samples tested on a vitros eciq immunodiagnostic system.Patient 1 sample result of 0.573 ng/ml vs.The expected result of <0.012 ng/ml patient 2 sample result of 0.108 ng/ml vs.The expected result of <0.012 ng/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros tropi es results were not reported outside of the laboratory and there were no allegations of patient harm as a result of the event.This report is number one of two 3500a forms filed for this event, as two devices were affected.(b)(4).
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