The investigation has determined that non-reproducible, lower than expected glucose (glu) results were obtained from a multiple patient samples processed using vitros chemistry products glu slides lot 0023-3233-9483 on a vitros 250 chemistry system.The assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0023-3233-9483 performance issue cannot be fully ruled out as a potential contributor to the event.However, 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 0023-3233-9483.Within-run vitros alkp precision testing was within ortho acceptable guidelines, verifying that the vitros 250 system was performing as expected and that an issue with the vitros 250 chemistry system is not a likely contributor to the event.Prior to the patient samples being run, the customer obtained acceptable quality control results from the same vitros glu reagent cartridge.This indicates that an issue with this particular vitros glu cartridge is not a likely contributor to the event, however it cannot be confirmed that the issue was not isolated to the slides in question.It is unknown if the customer is following the collection device manufacturers recommended protocol, therefore it is possible that improper pre-analytical sample processing contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
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