The customer reported false reactive architect (b)(6) results on multiple patients.The following data was provided (reference range: < 1.0 s/co = nonreactive, >= 1.00 s/co = reactive): patient #1 = 1.05 s/co (old), 0.31 s/co (new); patient #2 = 1.09 s/co (old), 0.62 s/co (new); patient #3 = 1.52 s/co (old), 0.62 s/co (new); patient #4 = 1.19 s/co (old), 0.39 s/co (new); patient #5 = 1.05 s/co (old), 0.30 s/co (new); patient #6 = 1.61 s/co (old), 0.48 s/co (new); patient #7 = 1.56 s/co (old), 0.53 s/co (new).The initial (b)(6) results with the old lot are reactive, repeat results using the new lot are nonreactive.There was no impact to patient management reported.
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The complaint investigation for false reactive results for seven samples tested with the architect havab-g assay 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 determined no related trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with the likely cause lot(s) and complaint issue.The overall performance of architect havab-g reagents in the field was reviewed using worldwide data and determined that the performance of the complaint lot(s) is acceptable.Product labeling review determined that the issue was adequately addressed.Based on the investigation, we have determined that there is no systemic issue and/or product deficiency for the architect havab-g reagent lot(s) identified in this complaint.Section d11: concomitant medical products and therapy dates: original: architect i2000sr analyzer ; changed to: architect i1000sr analyzer.
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