The investigation has determined that a lower than expected vitros ft4 result was obtained from a iqmh proficiency sample using a vitros immunodiagnostic products ft4 reagent on a vitros xt7600 integrated system.A definitive assignable cause for the lower than expected vitros ft4 result could not be determined with the information provided.Based on historical quality control results, a vitros ft4 lot 5200 performance issue is not a likely contributor to the event.Additionally, there is no indication of an instrument malfunction.Unexpected instrument performance is not a likely contributor to the event as biorad qc fluids and patient samples processed at the time of the event were as expected when using the vitros ft4 reagent lot 5200.Furthermore, handling and storage of the iqmh proficiency samples is an unlikely contributor to the event as samples were stored in line with the vitros ft4 instructions for use guidance and repeat testing of the discordant iqmh sample 4 in (b)(6) 2023 was well within the iqmh range for that sample.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 5200.
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