ADVIA 2400

[69754459] The customer contacted a siemens customer care center and stated that their quality controls were out of range. The customer performed calibration and reran quality controls, which were acceptable. The customer also determined that the patient results were elevated when quality controls were elevated and low when quality controls were low. The water purification system attached to the advia 2400 instrument uses a glycerol based lubricant to fit in the reverse osmosis membranes, which contaminated the water causing trig_2c to be discordant. When the customer performed calibration, the quality controls factored in and came back to normal. The water purification company was contacted by the customer to resolve the issue. The cause of the discordant tric_2c results on multiple patient samples was due to the contamination of water purification system. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10

[69754460] The customer obtained discordant concentrated triglyceride (trig_2c) results on multiple patient samples on an advia 2400 instrument. It is unknown if the discordant results were repeated or reported to the physician(s). Some of the samples were discarded by the sample storage module and therefore no samples were available for repeat testing. It is unknown if new samples were obtained for those patients and if repeat results were reported to the physician(s). The customer did not provide data. There are no reports of any impact on patient intervention or adverse health consequences due to the discordant trig_2c results.
Patient Sequence No: 1, Text Type: D, B5

[74804390] The initial mdr 2432235-2017-00184 was filed on march 10, 2017. Corrected information (4/24/2017): initial results on elevated patient results for trig_2 concentrated had been provided by the customer.
Patient Sequence No: 1, Text Type: N, H10