[46863214]
The customer contacted the siemens customer care center (ccc). The customer called regarding calibration issues with the method, which were resolved by recalibration. The customer then informed ccc of obtaining a discordant result. The customer calibrated a fresh reagent pack with a fresh calibrator. Quality controls were within range. The sample was then repeated, resulting lower. A customer service engineer (cse) was dispatched to the customer's site. The cse inspected the system and found no issues or problems. In a follow-up by the ccc it was discovered that the customer is calibrating every three (3) days and has the reagent set to do not use beyond. The customer is a high volume, using one reagent pack every 2-3 days. The customer is not calibrating each new reagent pack. Review of the events log, indicate no instrument issue. The customer stated that they have opened an internal complaint for improper reagent handling issue, and have put in place 7 day calibration and to calibrate all new reagent packs. As per advia centaur, advia centaur xp, and advia centaur xpt systems cancer antigen 27. 29 instructions for use, the user is to perform calibration every 7 days and requires a two-point calibration when changing lot numbers of primary reagent packs, replacing system components and when quality control (qc) results are repeatedly out of range. Technical applications specialist (tas) worked with the customer to resolve reagent handling issues by changing calibration to every 7 days and when a new pack is loaded. The cause of the discordant, cancer antigen 27. 29 results is due to a reagent handling issue by the user. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[46863215]
A discordant cancer antigen 27. 29 (ca 27. 29) result was obtained on one patient samples (patient 1) on an advia centaur xp instrument. The initial result was reported to the physician(s), who questioned it. The sample was repeated on the same advia centaur xp instrument, after recalibration, resulting lower. The customer pulled all patient samples reported on (b)(6) 2016 for ca 27. 29 to repeat testing. The samples were repeated at an alternate laboratory. The customer reported they had filed multiple amended reports. There are no known reports of patient intervention or adverse health consequences due to the discordant, cancer antigen 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5