ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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Catalog Number 07K65-39 |
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 02/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (b)(6).All available patient information was included.Additional patient details are not available.
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Event Description
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The customer observed falsely elevated architect free t4 results for multiple patient samples.The following data was provided (customer¿s reference range 0.70-1.48 ng/dl): (b)(6) 2024 sample id (b)(6) initial result on analyzer (b)(6) = 3.12 ng/dl, repeat on same analyzer = 1.46 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.7 ng/dl, repeat result on analyzer (b)(6) = 1.33 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.43 ng/dl, repeat on analyzer (b)(6) = 0.95 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.83 ng/dl, repeat on analyzer (b)(6) = 1.25 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.54 ng/dl, repeat result on analyzer (b)(6) = 1.17 ng/dl.No impact to patient management was reported.
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Manufacturer Narrative
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Section d4 - primary udi number: this section was corrected from (b)(4).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 in-house testing.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 search for similar complaints did identify an increase in complaint activity, however, no related trends were identified regarding commonalities for lot number 56001ud01 and issue for the product.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not identify any non-conformances, potential non-conformances, or deviations associated with lot number 56001ud01 and the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4, lot 56001ud01, was identified.
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Event Description
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The customer observed falsely elevated architect free t4 results for multiple patient samples.The following data was provided (customer¿s reference range 0.70-1.48 ng/dl): (b)(6) 2024.Sample id (b)(6) initial result on analyzer (b)(6) = 3.12 ng/dl, repeat on same analyzer = 1.46 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.7 ng/dl, repeat result on analyzer (b)(6) = 1.33 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.43 ng/dl, repeat on analyzer (b)(6) = 0.95 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.83 ng/dl, repeat on analyzer (b)(6) = 1.25 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.54 ng/dl, repeat result on analyzer (b)(6) = 1.17 ng/dl.No impact to patient management was reported.
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