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ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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| Catalog Number 07K65-77 |
| 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 02/24/2024 |
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Event Type
malfunction
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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 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 generated on the architect i2000sr processing module for multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l): initial result = 21.34 pmol/l, repeat result = 15.34 pmol/l.Initial result = 19.64 pmol/l, repeat result = 16.76 pmol/l.Initial result = 21.24 pmol/l, repeat result = 16.42 pmol/l.Initial result = 19.76 pmol/l, repeat result = 16.54 pmol/l.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation for falsely elevated architect free t4 results 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.Review of all the information provided by the customer was reviewed.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot shows elevated complaint activity; however, no trends were identified.Device history record review did not show any nonconformances, potential nonconformances or deviations associated with the likely cause list number and complaint issue.In house testing of retained of the likely cause lot met acceptance criteria and the product is performing as expected.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot number 53725ud02 was identified.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 generated on the architect i2000sr processing module for multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l) initial result = 21.34 pmol/l, repeat result = 15.34 pmol/l initial result = 19.64 pmol/l, repeat result = 16.76 pmol/l initial result = 21.24 pmol/l, repeat result = 16.42 pmol/l initial result = 19.76 pmol/l, repeat result = 16.54 pmol/l no impact to patient management was reported.Update: additional information provided by the customer on 30mar2024.The customer observed additional falsely elevated results for multiple samples.The following result were provided: initial result = 20.17 pmol/l, repeat result = 17.20 pmol/l initial result = 20.20 pmol/l, repeat result = 16.75 pmol/l 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 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 generated on the architect i2000sr processing module for multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l) initial result = 21.34 pmol/l, repeat result = 15.34 pmol/l initial result = 19.64 pmol/l, repeat result = 16.76 pmol/l initial result = 21.24 pmol/l, repeat result = 16.42 pmol/l initial result = 19.76 pmol/l, repeat result = 16.54 pmol/l no impact to patient management was reported.Update: additional information provided by the customer on 30mar2024.The customer observed additional falsely elevated results for multiple samples.The following result were provided: initial result = 20.17 pmol/l, repeat result = 17.20 pmol/l initial result = 20.20 pmol/l, repeat result = 16.75 pmol/l no impact to patient management was reported.
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Event Description
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The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l), initial result = 21.34 pmol/l, repeat result = 15.34 pmol/l, initial result = 19.64 pmol/l, repeat result = 16.76 pmol/l, initial result = 21.24 pmol/l, repeat result = 16.42 pmol/l, initial result = 19.76 pmol/l, repeat result = 16.54 pmol/l.No impact to patient management was reported.Update: additional information provided by the customer on (b)(6) 2024.The customer observed additional falsely elevated results for multiple samples.The following result were provided: initial result = 20.17 pmol/l, repeat result = 17.20 pmol/l, initial result = 20.20 pmol/l, repeat result = 16.75 pmol/l, no impact to patient management was reported.
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Manufacturer Narrative
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Corrected information in section d4 - primary udi number.
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