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 is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).
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The initial reporter stated that they received discrepant results for one patient sample tested with the elecsys tsh assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.The sample also had a discrepant result for the elecsys ft4 ii assay when tested on the second e 801 analyzer used for investigation.No incorrect results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The sample was initially tested with tsh on the reporter's e 801 analyzer.The sample was provided for investigation, where it was tested for tsh and ft4 on the second e 801 analyzer.The sample was repeated using the accuraseed method and the architect method.The serial number of the reporter's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 365417, with an expiration date of february 2020 was used on this analyzer.
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