The investigation determined that lower than expected vitros ck-mb results were obtained from multiple patient samples when run on a vitros 5600 integrated system.The results were considered lower compared to results obtained from the same samples tested using a non-vitros analyzer.The investigation was unable to determine the assignable cause of the event.The ortho technical solution center (tsc) was unable to obtain any other assay results or any specific clinical information regarding the patients.However, the customer reported the vitros ckmb results do not match the patient diagnosis.The tsc was unable to obtain any details regarding the pre-analytical sample collection, handling and storage of the samples used in the comparison and therefore, pre-analytical sample handling cannot be ruled out as a potential contributing factor.A review of quality control results for the month of february 2019 concluded that the performance of the vitros performance verifiers was acceptable; however, the quality control fluids were only processed 5-6 times the entire month of february.There are not enough qc data points processed in february 2019 to truly access the overall performance of the assay and therefore a ckmb lot 4940-0221-7109 issue cannot be ruled out as a contributing factor to this event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this lot of vitros ckmb slides.The tsc requested the customer process within run precision testing to confirm performance of the reagent and the analyzer.The precision testing has not been completed at this time and an instrument issue cannot be ruled out as a contributor to this event.
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