The complaint investigation for falsely elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 33108ud00 and the complaint issue.The overall performance of magnesium was reviewed using field data from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 33108ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot number 33108ud00.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the magnesium reagent for lot 33108ud00 was identified.
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