[2359239]
On (b)(6) 2011, because of erratic qc using siemens t4 assay, lot xxxxx146 on the advia centaur xp the company, siemens, was notified. We were told that other users had noticed the same issue. The company rep told us to remove and hand-mix the reagent pack daily, prior to use, to assure the primary reagent pack is properly mixed and all particles are removed from the sides of the pack (and to do this with future reagent packs until notified to stop). After this is performed, run qc material, ensure that the values are within established ranges, and if so then to use the reagent for pt testing. On (b)(6) 2011, the above process was followed along with performing linearity for the t4 assay. The qc cvs were low and acceptable and the assay determined to be linear. The operator therefore went ahead and also performed a proficiency survey consisting of five samples. The report of the proficiency showed high outlier failure for all samples. On (b)(6) 2011, siemens was called, because of the proficiency failure and asked to have an engineer investigate the instrument's function. After a full decontamination and repeat calibration check, no instrument malfunction could be found. After this field service the proficiency was repeated and all values were in acceptable limits. Qc performed prior to each run continues to be acceptable in conjunction with the pre-run manual mixing. On (b)(6) 2011 an "urgent field safety notice" (b)(4) was received reiterating the phone info received in august. To date, (b)(6) 2011, there has been no confirmed resolution of the reagent issue and siemens is now distributing lot xxxxx149 of reagent.
Patient Sequence No: 1, Text Type: D, B5