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Model Number FT4 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 09/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and difference in the standardization methodology used.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 one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The values measured at the customer site were reported outside of the laboratory.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated using the wako accuraseed method, and the abbott architect method.The sample was also provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of february 2021, was used on this analyzer.
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Search Alerts/Recalls
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