[106018304]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse replaced the acid and base pump and sample syringe, cleaned the wash station and luminometer, checked the acid, base, reagent, and sample dispenses, and calibrated the sample and reagent probes. A siemens regional support center specialist reviewed the instrument data, which was indicative that either there was no sample in the cuvette or there was no acid/base solution to create a reaction. Upon the follow-up visit, the cse checked the alignments and sample and reagent dispense. The cse replaced the reagent syringe and dilutor and checked the reagent probe, tip adapter and performance of wash blocks. The cse replaced the wash station, grey peri-pump waste tubings, snap platens on top of the peri-pumps, and dispense acid port. A siemens headquarters support center (hsc) specialist reviewed the service report and determined that several of the parts replaced and actions taken could have been the cause of the discordant result. The cause of the discordant psa result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required. Mdr 2432235-2018-00132 has been filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[106018305]
A discordant, falsely elevated prostate specific antigen (psa) result was obtained on one patient sample on an advia centaur cp instrument. It is unknown if the discordant result was reported to the physician(s). The sample was diluted with 1:10 and 1:2 dilution factors and run on same instrument, resulting lower. The sample was repeated neat on the same instrument, also resulting lower. A new sample draw was obtained from the patient and was run on the same instrument, resulting lower. One of the repeat results was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated psa result.
Patient Sequence No: 1, Text Type: D, B5