The customer observed a falsely elevated afp result for one patient while using the architect afp assay.The customer provided the following data: initial: 983.93 ng/ml, retest 1.75 ng/ml, retest on second analyzer: 1.8 ng/ml.There was no adverse impact to patient management reported.
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Further investigation of the customer issue included a review of the complaint text, in-house testing, field data review, a search for similar complaints, batch record review, design history record (dhr) review, and a review of labeling.Return material was not available.A review of the customer provided data and a review of the instrument logs confirmed the issue observed by the customer.An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for the architect afp assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results consistently therefore determined the reagent is performing acceptably.Tracking and trending did not identify an adverse trend or any atypical complaint activity.No issues were identified which would indicate a product deficiency from the batch record review.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information a deficiency of the architect afp reagent, list 03p36, lot 90235fn00 was not identified.
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