The investigation has determined that lower than expected vitros ft4 results were obtained from two different samples from a single patient when using vitros immunodiagnostic products free t4 (ft4) reagent on a vitros 5600 integrated system.The assignable cause for the lower than expected vitros ft4 results could not be determined with the information provided.Based on historical quality control results a vitros ft4 lot 4300 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systemic issue with vitros ft4 reagent lot 4300.Vitros tsh precision testing performed on the vitros 5600 integrated system was within ortho acceptable guidelines suggesting an instrument issue was not likely a contributing factor.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it could not be established if the customer was following the sample collection device manufacturer¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Furthermore, the presence of an unknown sample interferent cannot be completely ruled out as the cause of the discordant vitros results as no results using blocking tubes were provided by the customer.
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