The customer observed a falsely elevated alinity i free t4 result for one patient.The following data was provided: sample id (b)(6) initial result, on 15feb, was >5.00, repeat was 1.38 ng/dl.There was no impact to patient management reported.
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The complaint investigation for a falsely elevated alinity i free t4 results 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.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 57607ud00, stored at the recommended storage condition.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 57607ud00, was identified.
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