Discordant, falsely low alpha-fetoprotein (afp) results were obtained on one patient sample upon a 1:20 dilution and neat repeat on an advia centaur cp instrument.The discordant results were not released to the physician(s), as they did not match the patient¿s clinical history.The sample was repeated on the same instrument on a 1:10 dilution and post service, resulting as expected.The sample was also sent for testing at an alternate lab and the result matched the patient¿s clinical history.It is unknown which result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low afp results.
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A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse performed a total service visit.The cse replaced the sample syringe and performed a database cleanup, deleting results greater than 30 days old.Quality controls and a patient sample were run, resulting within range.The cause of the discordant, falsely low afp results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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