The customer contacted the siemens customer care center (ccc).The customer indicated that after replacing the q-gard, quality controls for levels 1 and 3 were within ranges and precision study for the sample in question, were satisfactory for all tests.Ccc instructed the customer to replace sample 1 probe as the sample probe counter exhibited elevated cycle counts reading.A siemens headquarter support center (hsc) specialist reviewed the data which indicated that qc results were within acceptable range, denoting proper method performance.The cause of the discordant, falsely elevated phos result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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A discordant, falsely elevated phosphorus (phos) result was obtained on a patient sample on a dimension vista 500 instrument.The discordant result was reported to the physician(s) who questioned it.The sample was repeated on the same dimension vista instrument, resulting lower.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 elevated phos result.
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