ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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Catalog Number 07P70-30 |
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 02/20/2024 |
Event Type
malfunction
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Event Description
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The customer observed falsely elevated alinity i free t4 results for multiple samples.The following data was provided: sid (b)(6), initial result (b)(6) = 19.7 pmol/l, repeat (b)(6) = 27.1 pmol/l.Sid (b)(6), initial result (b)(6) = 16.6 pmol/l, repeat (b)(6) = 22.4 pmol/l.The customer is questioning the repeat results generated on (b)(6).No impact to patient management was reported.
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Manufacturer Narrative
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Completed information for section a1 patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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Section d4 primary udi number was updated from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 56201ud00, however, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 56201ud00 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 alinity i free t4 for lot 56201ud00 was identified.
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Event Description
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The customer observed falsely elevated alinity i free t4 results for multiple samples.The following data was provided: sid (b)(6) initial result ((b)(6)) = 19.7 pmol/l, repeat ((b)(6)) = 27.1 pmol/l sid (b)(6) initial result ((b)(6)) = 16.6 pmol/l, repeat ((b)(6)) = 22.4 pmol/l no impact to patient management was reported.
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Search Alerts/Recalls
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