The investigation has determined that a higher than expected glucose csf (glu-ca) result was obtained from a vitros liquid performance verifier (lpv) using vitros xt chemistry products glu-ca slides lot 7418-0015-1820 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined.As there was not enough historical qc results to adequately evaluate the performance of the reagent, an issue related to vitros xt glu-ca slides lot 7418-0015-1820 cannot be ruled out as a contributor of the event.The results of vitros alkp diagnostic precision testing performed on the vitros xt 7600 integrated system were within acceptable guidelines indicating that an instrument related issue was not likely a contributor of the event.However, as the precision testing was not performed around the timeframe of the event, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.As the customer used an alternate set of vitros lpv fluids to obtain acceptable results, an issue related to the performance of vitros lpv i lot w9322 cannot be ruled out as a contributor of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros xt glu-ca slides lot 7418-0015-1820.
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