The customer questioned results for 1 patient sample tested for elecsys ft4 ii (ft4 ii), elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) on a cobas e801 module.The patient sample was submitted for investigation.Based on the data provided, discrepant results were identified for ft4 ii and ft3 iii between the customer's e801 module, a cobas e801 module used at the investigation site, a cobas 6000 e 601 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the centaur method.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier pt-23266 for information on the ft3 iii results.Refer to attached data for the patient results.It is not known if any incorrect results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer's e801 module serial number was not provided.The e601 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used with the e601 module and the e411 analyzer was 288197 with an expiration date of 31-dec-2018.The ft4 ii reagent lot number used with the e801 module at the investigation site was 225159 with an expiration date of 31-may-2018.
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