The customer questioned thyroid results for 7 patient samples tested for elecsys tsh (tsh), elecsys ft4 iii (ft4 iii), and elecsys ft3 iii (ft3 iii) on a cobas e 801 module.The 7 patient samples were submitted for investigation where discrepant results were identified for tsh, ft4 iii and ft3 iii between the customer's e801 module, the centaur method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.It is not known if any incorrect results were reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the tsh results.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e602 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 iii reagent lot number used with the e602 module was 331797 with an expiration date of 30-may-2019.The ft4 iii reagent lot number used with the e411 analyzer was 331797 with an expiration date of 30-may-2019.The ft4 iii reagent lot number used with the e801 module at the investigation site was 331807 with an expiration date of 30-may-2019.Calibration and qc data at the investigation site was acceptable.Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case siemens, can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined.
|