The customer observed a false non-reactive architect syphilis tp result for a 63 year old male patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id: (b)(6), initial result = 0.08 s/co, repeat result = 0.09 s/co, rapid plasma reagin (rpr) = 1:16 (positive).No impact to patient management was reported.
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The complaint investigation for false nonreactive architect syphilis results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, in house testing of a retained reagent kit, and return sample testing was completed.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 37093be01 and the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the lot generates the expected results.Labeling was reviewed and sufficiently addresses the customer's issue.The returned specimen sample id (b)(6) was tested with the following results: architect syphilis tp: 0.09 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.In-house testing of the return sample was performed with architect syphilis tp lot 41106be01, due to the complaint lot 37093be01 not being available for testing.No discrepant results were generated.Based on the investigation, no systemic issue or deficiency with the architect syphilis reagent lot 37093be01 was identified.
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