The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3.The sample was initially tested at the customer site on an e602 analyzer.The first run results obtained at the customer site were reported outside of the laboratory.The sample was then provided for investigation, where it was tested on a cobas 6000 e 601 module (e601) and cobas e 411 immunoassay analyzer (e411).Refer to the attachment for all data.No adverse events were alleged to occur with the patient.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 185414, with an expiration date of november 2017 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 185414, with an expiration date of november 2017 was used on this analyzer.
|