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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Manufacturer Narrative
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Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).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 alinity i free t4 (ft4) results on one patient.The one result example provided were: on 19feb2024 sid (b)(6)initial = 21.11 pmol/l /repeated on 20feb2024=14.28 pmol/l /on 20feb2024 on alinity ai01438=12.65 and 13.38 pmol/l laboratory reference range for ft4= 8.9 to 17.3 pmol/l there was no reported impact to patient management.
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Event Description
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The customer observed falsely elevated alinity i free t4 (ft4) results on one patient.The one result example provided were: on (b)(6) 2024 sid (b)(6) initial = 21.11 pmol/l /repeated on (b)(6) 2024=14.28 pmol/l /on (b)(6) 2024 on alinity (b)(6) =12.65 and 13.38 pmol/l.Laboratory reference range for ft4= 8.9 to 17.3 pmol/l there was no reported impact to patient management.
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Manufacturer Narrative
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Updated d4 primary udi number: (b)(4).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 alinity i free t4 result reagent lot: 56201ud00.The ticket search determined that reagent lot shows higher complaint activity than expected for this product.A review of tracking and trending data did not identify any related trends for the product for the issue.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.In-house testing was completed using an in-house retained kit.All specifications were met indicating that the lot is performing acceptably.A review of the labeling addresses the customer¿s issue.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 alinity i free t4 result reagent lot: 56201ud00.
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Search Alerts/Recalls
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