The customer reported false nonreactive alinity i anti-hcv results for a (b)(6) female diagnosed with residual gastric ulcer.The following information was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): previous patient history: (b)(6) 2020 = hcv result = 0.42 s/co.(b)(6) 2020= hcv result = 0.62 s/co.(b)(6) 2020 = hcv result = 0.38 s/co.On (b)(6) 2020 = alinity hcv result = 0.57 s/co (nonreactive) / repeat result = 0.65 s/co (nonreactive).On (b)(6) 2021 = roche platform hcv result = 40.6 (reactive) / colloidal gold standard method = weakly positive.On (b)(6) 2021, additional testing was provided by the customer: high sensitivity hcv rna testing (cobas taqman): hcv rna was not detected there was no impact to patient management reported.
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The complaint investigation for false nonreactive alinity i anti-hcv results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and in-house testing of a retained reagent kit of the complaint lot was cpmpleted.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for the product.Trending review determined no trends identified for the product for the issue.The device history record was reviewed, and no non-conformances or deviations were identified with the reagent lot and complaint issue.Sensitivity testing was completed using an in-house retained reagent kit of the complaint lot 25303be01.All specifications were met, and no false non-reactive results were obtained, showing that the lot generates the expected results.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for alinity i anti-hcv reagent lot 25303be01 was identified.
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