ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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Catalog Number 07K65-78 |
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 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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All available patient information was included, no additional patient information was available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer observed falsely elevated architect free t4(ft4) results on three patients.The following data was provided.Sid 1: initial result 1.58 ng/dl, repeat results 1.38 ng/dl & 1.2 ng/dl.Sid 2: initial result 1.85 ng/dl, repeat results 1.34 ng/dl & 1.13 ng/dl.Sid 3: initial result 1.49 ng/dl & repeat results 1.49 ng/dl & 1.24 ng/d.The customer uses reference range 0.7-1.48 ng/dl, there was no reported impact to patient management.
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Manufacturer Narrative
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D4: primary udi number updated from (b)(4) to (b)(4).Section h4: device mfg date was updated from: 7/9/2023 to 07/29/2023.All available patient information was included, no additional patient information was available.The complaint evaluation 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 for architect free t4 reagent lot: 53725ud03.There was an increase in complaint activity, however, no related trends were identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the architect free t4 reagent lot: 53725ud03.
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Event Description
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The customer observed falsely elevated architect free t4(ft4) results on three patients.The following data was provided.Sid 1: initial result 1.58 ng/dl and repeat results 1.38 ng/dl and 1.2 ng/dl; sid 2: initial result 1.85 ng/dl and repeat results 1.34 ng/dl and 1.13 ng/dl; sid 3: initial result 1.49 ng/dl and repeat results 1.49 ng/dl and 1.24 ng/dl.The customer uses reference range 0.7-1.48 ng/dl, there was no reported impact to patient management.
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Search Alerts/Recalls
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