The customer observed imprecise alinity free t4 results for 4 patients.The following data was provided: sid (b)(6), initial result processed on (b)(6) = 31.5 repeated on (b)(6) results =18.01 and 22.62.Sid (b)(6), initial result processed on (b)(6) = 44.1 repeated on (b)(6) results = 13.74 and 13.84.Sid (b)(6), initial result processed on (b)(6) = 50.3 repeated on (b)(6) results =29.61 and 18.80.Sid (b)(6), initial result processed on (b)(6) = 37.1 repeated on (b)(6) results =53.10 and 23.13.Package insert reference range = 9.01-19.05 pmol/l there was no impact to patient management reported.
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The complaint investigation for a falsely elevated alinity i free t4 result included a search for similar complaints, the review of complaint text, trending data, labeling, device history records, and testing of retained reagent kit.Return testing was not completed, as returns were not available.Retained analysis of alinity i free t4 reagent lot 56201ud00.All specifications were met indicating that the lot is performing acceptably.Trending review determined no related trend for the issue for the product.Device history record review did not identify any non-conformances or deviations for the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i free t4, lot number 56201ud00, was identified.
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