The investigation determined that three higher than expected vitros troponin i es (tropi es) results were obtained from a single patient sample and two higher than expected vitros nt ¿ probnp (ntbnp) results were obtained from the same patient sample when tested on a vitros eciq immunodiagnostic system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tropi es lot 3360 performance issue is not a likely contributor to the event.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagent lot 3360 at, or below the url concentration of 0.034 ng/ml cannot be determined and a vitros tropi es lot 3360 reagent issue could not be entirely ruled out as contributing to the event.Additionally, a vitros ntbnp lot 2170 reagent issue cannot be ruled out as a contributor to the event, as despite the accuracy of the historical quality control results being within acceptable guidelines, the quality control data exhibited poor within laboratory precision.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tropi es reagent lot 3360 or vitros ntbnp lot 2170.Precision testing performed on the vitros eciq immunodiagnostic system was not completed according to ortho guidelines and therefore, it is not possible to completely rule out an instrument issue as a potential contributor to the events.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to established if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected sample, although this could not be confirmed.
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