The investigation confirmed that higher than expected ckmb results were obtained from a patient sample processed using vitros ckmb reagent lot 2960 on a vitros 5600 integrated system.The assignable cause of the event was not determined.The patient has breast cancer was receiving chemotherapy.It is possible that the higher than expected vitros ckmb results are due to an unknown sample related issue that only impacts the vitros assay and not the beckman assay.However, no additional investigation was performed to confirm or rule out a sample related issue.The ckmb quality control results were reviewed and some of the results around the time of the event were unacceptable.In addition, there was no documentation to confirm pre-analytical qc fluid handling and storage.No definitive conclusion can be made regarding the qc performance in combination with vitros ckmb lot 2960 and a vitros ckmb reagent issue could not be ruled out as a potential contributing factor to the event.There was no evidence of an instrument malfunction.However, diagnostic precision testing was not conducted on the instrument around the time of the event.Therefore, an instrument issue cannot be ruled out as a contributor to the event.The sample was a serum sample spun for 5 minutes at an rcf 2860.The tube manufacturer was not provided and therefore it is unknown if the sample was processed in accordance with the sample collection device manufacturer's recommendations.Therefore, a pre-analytical sample handling cannot be ruled out as a potential contributing factor to the event.A complaint review found no additional complaints for qc high or precision issues using this ckmb lot.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros ckmb lot 2960.A definitive assignable cause for the event could not be determined.Email address for contact office in is (b)(4).
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