ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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Catalog Number 07K65-29 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2024 |
Event Type
malfunction
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Event Description
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The customer observed falsely elevated architect free t4 results for two patients.The following data was provided: (b)(6).Free t4 first result 2.10 ng/dl, repeated 1.45 ng/dl, free t3 result 2.95 pg/ml, tsh result 0.9694 miu/ml; (b)(6).Free t4 first result 1.90 ng/dl, repeated 1.03 ng/dl, free t3 result 2.64 pg/ml, tsh result 1.2565 miu/ml.Reference ranges: free t4 normal range 0.70 - 1.48 ng/dl free t3 normal range 1.58 - 3.91 pg/ml tsh normal range 0.35 - 4.94 uiu/ml no impact to patient management was reported.
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review of customer data aligned with customer¿s issue and no additional issues were identified.Ticket trending review did not identify any trends.Device history record review was performed on lot 56026ud00, which did not show any potential non-conformances, deviations, or non-conformances related to the issue under review.Retained analysis of alinity i free t4 reagent lot 56026ud00.Testing met acceptance criteria and the product is performing as expected.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.
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