The investigation included a review of the submitted data, product historical data, and product labeling.Trending review did not identify any trends for the complaint issue.Review of the background and qc results found that the results were within limits for all parameters; however, review of the precision report found that the %cv result for rdw was outside of the limits provided by the cell-dyn emerald operator¿s manual (9213301c¿december 2020).The operator¿s manual states that, "fresh whole blood specimens used to verify imprecision specifications should have mean values that fall within the range tested in [table 4.9]." "specimens with values outside these ranges may have higher or lower %cv." all other parameter were within range for precision.Review of the patient specimen reports from the cell-dyn emerald analyzer found that the wbc results were invalidated and flagged on both runs and the plt results were also flagged on 1 of 2 runs for patient 1, indicating that further review was required.The patient report from the analyzer for patient 2 was not available for review.The cell-dyn emerald operator¿s manual (9213301c¿december 2020), states that the wbc and plt measurand flags indicate that the, "result[s] may be suspect due to interfering substances or the inability of the instrument to measure a particular measurand due to a sample abnormality.The name of each flag, how it is displayed, the cause of the flag, and the action to be taken are given in [table 3.4 wbc flags and table 3.5 platelet flags]." the operator's manual also states that the, "cell-dyn emerald has been validated for its intended use.However, error can occur due to potential operator errors and system technology limitations.Results obtained from the system should be used with other clinical data, for example, patient symptoms, other test results, patient history, clinical impressions, information available from clinical evaluation, and other diagnostic procedures.All data should be considered for patient care management.If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." the operator's manual also provides steps on how to troubleshoot measurand related problems in section 10, "troubleshooting" in, "table 10.1 measurand-related problems." labeling was found to be adequate for the complaint issue.Trending review did not identify any trends for the complaint issue.
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