The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the wako accuraseed method.The results from the e801 module were reported outside of the laboratory.The patient sample was submitted for investigation where discrepant results were identified for ft3 iii, elecsys tsh (tsh), elecsys ft4 iii (ft4 iii) and elecsys ft4 ii (ft4 ii) between the customer's e801 module, the abbott architect method, the accuraseed method and an e801 module used at the investigation site.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results, medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft4 iii results.The customer's e801 module serial number was (b)(4).
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The patient sample was submitted for investigation.No interfering factor was identified in the sample.The investigation did not identify a product problem.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.
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