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 03/24/2024 |
Event Type
malfunction
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Event Description
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The customer observed falsely elevated architect free t4 results for multiple samples.The following data was provided: (b)(6) 2024 sid (b)(6) initial result = 20.39, repeat = 19.(b)(6) 2024 sid (b)(6) initial result = 19.47, repeat = 16.89.(b)(6) 2024 sid (b)(6) initial result = 20.51, repeat = 17.53.(b)(6) 2024 sid (b)(6) initial result = 19.24, repeat = 16.78.(b)(6) 2024 sid (b)(6) initial result = 21.6, repeat = 17.24.(b)(6) 2024 sid (b)(6) initial result = 20.73, repeat = 18.25.(b)(6) 2024 sid (b)(6) initial result = 19.74, repeat = 17.76.(b)(6) 2024 sid (b)(6) initial result = 21.46, repeat = 18.64.(b)(6) 2024 sid (b)(6) initial result = 21.51, repeat = 16.17.(b)(6) 2024 sid (b)(6) initial result = 19.73, repeat = 17.89.(b)(6) 2024 sid (b)(6) initial result = 20.83, repeat = 15.84.(b)(6) 2024 sid (b)(6) initial result = 34.61, repeat = 12.86.(b)(6) 2024 sid (b)(6) initial result = 23.56, repeat = 17.52.(b)(6) 2024 sid (b)(6) initial result = 22.82, repeat = 15.87.(b)(6) 2024 sid (b)(6) initial result = 19.6, repeat = 17.59.(b)(6) 2024 sid (b)(6) initial result = 32.86, repeat = 15.95.(b)(6) 2024 sid (b)(6) initial result = 20.46, repeat = 17.29.(b)(6) 2024 sid (b)(6) initial result = 22.18, repeat = 18.2.(b)(6) 2024 sid (b)(6) initial result = 20.53, repeat = 18.46.(b)(6) 2024 sid (b)(6) initial result = 19.07, repeat = 15.86.(b)(6) 2024 sid (b)(6) initial result = 19.87, repeat = 17.28.(b)(6) 2024 sid (b)(6) initial result = 20.14, repeat = 16.17.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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Manufacturer Narrative
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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 for lot 53725ud02, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, in-house performance testing was completed which indicates the product is performing as expected.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 architect free t4 for lot 53725ud02 was identified.
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Event Description
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The customer observed falsely elevated architect free t4 results for multiple samples.The following data was provided: (b)(6) 2024 sid (b)(6) initial result = 20.39, repeat = 19 (b)(6) 2024 sid (b)(6) initial result = 19.47, repeat = 16.89 (b)(6) 2024 sid (b)(6) initial result = 20.51, repeat = 17.53 (b)(6) 2024 sid (b)(6) initial result = 19.24, repeat = 16.78 (b)(6) 2024 sid (b)(6) initial result = 21.6, repeat = 17.24 (b)(6) 2024 sid (b)(6) initial result = 20.73, repeat = 18.25 (b)(6) 2024 sid (b)(6) initial result = 19.74, repeat = 17.76 (b)(6) 2024 sid (b)(6) initial result = 21.46, repeat = 18.64 (b)(6) 2024 sid (b)(6) initial result = 21.51, repeat = 16.17 (b)(6) 2024 sid (b)(6) initial result = 19.73, repeat = 17.89 (b)(6) 2024 sid (b)(6) initial result = 20.83, repeat = 15.84 (b)(6) 2024 sid (b)(6) initial result = 34.61, repeat = 12.86 (b)(6) 2024 sid (b)(6) initial result = 23.56, repeat = 17.52 (b)(6) 2024 sid (b)(6) initial result = 22.82, repeat = 15.87 (b)(6) 2024 sid (b)(6) initial result = 19.6, repeat = 17.59 (b)(6) 2024 sid (b)(6) initial result = 32.86, repeat = 15.95 (b)(6) 2024 sid (b)(6) initial result = 20.46, repeat = 17.29 (b)(6) 2024 sid (b)(6) initial result = 22.18, repeat = 18.2 (b)(6) 2024 sid (b)(6) initial result = 20.53, repeat = 18.46 (b)(6) 2024 sid (b)(6) initial result = 19.07, repeat = 15.86 (b)(6) 2024 sid (b)(6) initial result = 19.87, repeat = 17.28 (b)(6) 2024 sid (b)(6) initial result = 20.14, repeat = 16.17.No impact to patient management was reported.
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Search Alerts/Recalls
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