The customer observed a falsely elevated alinity i free t4 results and a falsely depressed alinity i tsh result for one sample.The following data was provided: sid (b)(6).Initial free t4 result = 1.69 ng/dl, repeat = 1.26 ng/dl initial tsh result = 4.31 uiu/ml, repeat = 9.62 uiu/ml no impact to patient management was reported.
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The customer observed a falsely elevated alinity i free t4 results and a falsely depressed alinity i tsh result for one sample.The following data was provided: initial free t4 result = 1.69 ng/dl, repeat = 1.26 ng/dl initial tsh result = 4.31 uiu/ml, repeat = 9.62 uiu/ml no impact to patient management was reported.
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Section d4 primary udi number was updated from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify trends for list number 07p70, however, an increase in complaint activity for lot 53312ud00 was not identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 53312ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot 53312ud00 was identified.
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