The customer contacted the siemens customer care center (ccc) to report the discordant glucose result.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse found that the service undermix method failed on sample 1 (s1) probe.The cse replaced s1 mixer and realigned probe.The cse ran mixer diagnostic and quick check, which passed.The cse checked s1 undermix, overmix, align and fluidics methods, which were acceptable.The cse re-calibrated glucose.The cse ran quality control and precision test on glucose sample, which were acceptable.The cause of the discordant glucose result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.
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A discordant, falsely low glucose result was obtained on one patient sample on a dimension vista 500 instrument.The initial result was not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The repeat result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glucose result.
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