The investigation determined that non-reproducible, higher than expected vitros glucose (glu) results were obtained from ten different patient samples tested on a vitros xt7600 integrated system.The most likely assignable cause for this event could not be determined.All the higher than expected vitros glu results for patient samples 1 -5 were obtained from the same slide cartridge, and all the higher than expected vitros glu results for patient samples 6 - 10 were obtained from the same, alternate slide cartridge, indicating a potential performance issue with the vitros glu lot 0023-3233-9086 slides in use at the time of the events.However, acceptable vitros glu slide lot 0023-3233-9086 patient sample and biorad quality control sample results were obtained using slides from the same slide affected cartridges, indicating a potential performance issue with some, but not all vitros glu slides from the affected slide cartridges.Based on historic quality control results, there was no indication that vitros glu slide lot 0023-3233-9086 malfunctioned.Based on acceptable diagnostic vitros alkp and glu within-run precision testing, the vitros xt7600 integrated system was performing as intended and did not likely contribute to the event.A review of sample drop metering pressure profiles from the affected samples were typical to expected pressure profiles, which also indicates the vitros xt7600 integrated system was performing as intended and did not likely contribute to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer was not 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.Continual tracking and trending of complaints identified a slight increase in complaints for both lower and higher than expected, non-reproducible results using vitros glu slide lot 0023-3233-9086, and with vitros glu slides from coating 3233.This indicates a potential performance issue with vitros glu slides from coating 3233.
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