The investigation determined that a higher than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii reagent on three (3) different vitros xt 7600 integrated systems.A definitive cause for the higher than expected patient sample result could not be determined.Historical quality control data indicates some within-lab vitros b-hcg imprecision for the biorad control, however, the imprecision was slight when compared to the magnitude of bias associated with the higher than expected vitros b-hcg patient result.Therefore, a vitros b-hcg reagent issue is an unlikely contributor to this event but cannot be completely ruled out as a contributing factor.The ortho tsc requested the customer to perform diagnostic within run precision testing to verify the performance of the vitros xt 7600 integrated systems, however, the customer has not carried out any precision testing on the instruments.Additionally, no precision testing was carried out at the time of the events, therefore, an instrument issue cannot be ruled out as contributing to these events.Pre-analytical sample handling could not be ruled out as a potential contributing factor as the tsc was unable to determine if the customer was following the sample collection device manufacture's recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Additionally, a possible patient sample mix-up contributed to the event.The customer indicated that it was possible that the initial sample tube was mislabeled, although this could not be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg lot 3930.
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