Catalog Number 09043284190 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer serial number was not provided.The patient sample was requested for investigation.The investigation is ongoing.
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Event Description
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There was an allegation of questionable elecsys ft4 iv assay results for 1 patient sample on a cobas e 601 analytical unit.The initial ft4 result was 30 pmol/l.The sample was sent to another laboratory and tested on an abbott architect.The abbott ft4 result was 17.2 pmol/l.The elecsys ft4 reference range is 11.4 - 22 pmol/l.The abbott ft4 reference range is 8.5 - 22.5 pmol/l.
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Manufacturer Narrative
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The investigation did not identify a product problem.It was determined that the result differences generated between the different methods are consistent with methodological differences.
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Search Alerts/Recalls
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