The investigation determined that lower than expected vitros glucose (glu) results were obtained from multiple patient samples when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros glu reagent lot 0049-0967-1567 performance issue is not a likely contributor of the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0049-0967-1567.A review of e-connectivity data from the vitros 5600 integrated system determined that over the timeframe of the event, there were separate groupings of patient sample results of <20 mg/dl from two different reagent slots in the vitros 5600 integrated system.In addition, between the groupings of the lower than expected results there were other patient sample results that were within expectations.This indicates that a non-reactive vitros glu slide cartridge is not a likely cause of the event.It is possible an issue with the affected slides contributed to the event, but this cannot be confirmed.An ortho field engineer (fe) performed adjustments to the microslide metering assembly of the vitros 5600 integrated system.Post service marker precision testing on the vitros 5600 integrated system yielded results that were within acceptable guidelines indicating that the instrument had been returned to expected operation.However, because precision testing was not conducted prior to service actions an issue with the vitros 5600 integrated system cannot be concluded nor ruled out as a contributor to the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.
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