The investigation determined that higher than expected vitros carbamazepine (crbm) results were obtained from a single level of non-vitros biorad immunoassay plus control lot 85310 tested on a xt7600 integrated system.The assignable cause of the event could not be determined.Pre-analytical sample mix-up between the biorad level 2 and level 3 control fluids is a potential cause of the event as the higher than expected biorad level 2 results are similar to the results obtained from the biorad level 3 control fluid.The customer could verify if pre-analytical sample mixup occurred, therefore, an issue with the vitros crbm slides in use at the time of the event could not be ruled out as the assignable cause.Vitros crbm results obtained from vitros therapeutic drug monitoring performance verifier fluids within the timeframe of the event were within established ranges, indicating acceptable accuracy after the event.However, no vitros tdm pv fluids were tested within the timeframe of the event, and it is unknown if vitros crbm lot 3913-0122-3158 was performing as intended when the event occurred.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product crbm slides, lot 3913-0122-3158.The customer made no indication the vitros xt7600 system was not performing as intended, however, since no diagnostic within-run precision test was performed to assess instrument performance, an instrument related performance issue cannot be completely ruled out as contributing to the event.
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