The customer observed a falsely elevated magnesium result generated on an alinity c processing module for one patient.The following results were provided: sid (b)(6): initial: 0.43, repeated: 0.63, repeat on different analyzer: 0.40.There was no impact to patient management reported.
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A search for similar complaints and ticket trending review did not identify any trends or issues with the complaint lot number or current complaint issue.Device history record review did not identify any non-conformances or deviations related to the complaint lot and complaint issue.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency was identified for the alinity c magnesium reagent, lot 40152ud00.
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