The investigation has determined that a lower than expected vitros ft4 result was obtained from a single patient sample using a vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The definitive assignable cause of the event was not be determined.The likely contributor to the event is an instrument related issue.An ortho field engineer (fe) performed service & maintenance actions on numerous subsystems including the well wash and signal reagent subsystems.Following service actions, the ortho fe processed performance tests to verify the instrument operation.However, as no pre-service within run precision testing was performed by the customer or the ortho fe to verify the instrument performance prior to service and maintenance actions, it cannot be definitively confirmed that the vitros 5600 integrated system was the cause of the event.It was not possible to establish if the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol.In addition, no details were provided on patient sample handling on the day of the event.Therefore, pre-analytical sample handling cannot be ruled out as a contributing factor.Based on historical quality control results, a vitros ft4 lot 5240 performance issue is not a likely contributor to the event.In addition, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 5240.
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