The investigation determined that a higher than expected vitros potassium (k+) result was obtained from a single patient sample tested on a vitros xt 7600 integrated system.The assignable cause of the event could not be determined.Improper pre-analytical sample processing could not be ruled out as a contributing factor.The customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample, although this could not be confirmed.In addition, vitros na+ and k+ within-run precision testing performed was within acceptable guidelines, indicating the vitros na+ and k+ assays were performing as intended on the vitros xt7600 integrated system suggesting an instrument issue was not likely a contributing factor.However, the vitros na+ within-run precision test was not performed according to the guidelines required to completely assess the performance of the vitros xt7600 integrated system, therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.Finally, historical vitros k+ quality control results obtained from vitros k+ slide lot 4102-1116-5144 were acceptable, indicating the slide lot was performing as intended prior to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ slide lot 4102-1116-5144.
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