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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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 reported a falsely elevated alinity i free t4 result on a patient.The following results were provided: sid (b)(6) = > 64.35 pmol/l, another alinity = 12.7 pmol/l (reference range: (b)(4) = 19 pmol/l).No impact to patient management was reported.
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Event Description
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The customer reported a falsely elevated alinity i free t4 result on a patient.The following results were provided: sid (b)(6) = > 64.35 pmol/l, another alinity = 12.7 pmol/l (reference range: 9 = 19 pmol/l).No impact to patient management was reported.
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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.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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Search Alerts/Recalls
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