The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.The service was performed over multiple visits.The cse found no system issues.The cse checked the wash manifold, aspiration of probe 1,2,3 and 4, vacuum pump, aspiration performance, dispense performance, sample syringe and diluter and verified that the volumes were accurate and consistent , and checked reagent packs, incubation ring magnet, acid and base dispense, which were acceptable.The cse verified that the luminometer was dry and clean.The cse performed luminometer darkcounts and results were acceptable.The cse tested dry, wet water, and wet wash and provided results, which were acceptable.The cse performed precision testing of 30 replicates to verify precision of estradiol, psa, and vitamin b12, which were acceptable.The cause of the discordant psa result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 2432235-2017-00582 was filed for the same event.Mdr 2432235-2017-00583 was filed for the same event.
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Inconsistent prostate specific antigen (psa) results were obtained, between the initial and repeat runs, on one patient sample on a advia centaur xpt instrument.The sample was repeated twice on the same instrument, resulting higher than the initial result.It is unknown which result was discordant and if the result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant psa result(s).
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The initial mdr 2432235-2017-00578 was filed on oct 26, 2017.Corrected information (10/27/2017): the initial psa result was discordant and the second repeat result was considered the correct result and was reported to the physician(s).This information has been updated.Additional information (10/27/2017): a siemens headquarter support center (hsc) specialist reviewed the event and concluded that while there may have been a system issue that corrected during the system checks , no system issue could be identified.The cause could not be determined.Mdr 2432235-2017-00582_s1 was filed for the same event.Mdr 2432235-2017-00583_s1 was filed for the same event.
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