The customer questioned results for 1 patient tested for elecsys ft4 ii (ft4 ii), tsh, anti-tpo and anti-tshr on a cobas e 801 module.Refer to the associated medwatches with the following patient identifiers: (b)(6).Between (b)(6) 2017 and (b)(6) 2018 the patient had increased ft4 ii results (29-52 pmol/l) and low tsh results (0.04 - 0.17 mie/l) in 14 different samples from the patient when tested on the e801 module.Anti-tpo results were > 600 ie/ml in 6 different samples from the patient when tested on the e801 module.The patient previously had negative anti-tshr results in 2 different samples when tested by the (b)46) method, however, when the customer changed to the roche method in (b)(6) 2017, the patient had positive anti-tshr in 7 different samples when tested on the e801 module.The actual results were not provided.The roche results were reported outside of the laboratory where the patient was diagnosed with hyperthyroidism and treatment was started with neo-mercazole in (b)(6) 2017.The customer suspects an interference in the patient sample as the patient's clinical symptoms do not agree with the results.The customer sent 3 patient samples obtained in (b)(6) 2018 and (b)(6) 2018 for testing by the abbott architect method.Discrepant results were identified for ft4 ii and tsh between the e801 module and the abbott method.Refer to attached data for the patient comparison results.After the patient samples were tested by the abbott architect method, neo-mercazole treatment was stopped.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).
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