Model Number FT4 G3 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/24/2019 |
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 one patient sample tested with the elecsys tsh assay and the elecsys ft4 iii assay on a cobas 8000 e 801 module.The values measured on the e 801 analyzer were reported outside of the laboratory.The tsh value for the sample was unexpected, so it was repeated on an abbott architect analyzer.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.The serial number of the customer's e 801 analyzer is (b)(4).
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Manufacturer Narrative
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A second sample from the patient also had discrepant results for ft4 when tested on the customer's e801 analyzer and a second e801 analyzer used for investigation.This sample was initially tested on 28-dec-2019, resulting with a ft4 value of 2.20 ng/dl when tested on the customer's e 801 analyzer (as reported in initial medwatch).This sample was repeated on an abbott analyzer, resulting with a ft4 value of 1.67 ng/dl.This sample was repeated on a second e 801 analyzer used for investigation on 25-feb-2020, resulting with a ft4 value of 2.15 ng/dl.
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Manufacturer Narrative
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The investigation could not identify a product problem.The cause of the event could not be determined.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 differences in the standardization methodology used.
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Search Alerts/Recalls
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