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Model Number FT3 G3 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The initial reporter stated they received discrepant results for two samples from the same patient tested with elecsys ft3 iii and the elecsys ft4 iii assay on a cobas 8000 e 801 module analyzer.The second sample had discrepant ft3 and ft4 results when tested on a second e 801 analyzer used for investigation.The second sample also had a discrepant ft3 result when tested on an e411 analyzer used for investigation.No incorrect results were reported outside of the laboratory.This medwatch will apply to the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The first patient sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The second sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.Both samples were repeated on an abbott architect analyzer.The second sample was repeated on a siemens centaur analyzer.The second sample was tested on an e 801 analyzer and an e411 analyzer used for investigation on (b)(6) 2020.The serial number of the customer's e 801 analyzer is (b)(4).The ft3 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft3 reagent lot number 476059, with an expiration date of august 2021 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft3 reagent lot number 473372, with an expiration date of may 2021 was used on this analyzer.
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Manufacturer Narrative
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Further investigations of one sample from the patient determined it contains an interfering factor against the streptavidin component of the ft3 and ft4 assays.The sample may also contain an interfering factor against the ruthenium component of these assays, but this could not be confirmed with certainty.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".
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Search Alerts/Recalls
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