A siemens customer service engineer (cse) was dispatched to the customer's site.The cse reviewed the data provided.The cse found multiple aliquot clot detect errors and probe errors during aspiration of the check reagent.The cse found gel on the aliquot probe and the aptio vista buffer tube static discharge plate was dirty.The cse cleaned the static discharge plate and all spills.The cse replaced the aliquot probe and ran auto-alignment.The cse performed a quickcheck, resulting within specification and range.The cse performed quality control (qc), resulting within range.The customer performed a precision test, resulting within range.The cause of the discordant, falsely elevated total bilirubin results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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Discordant, falsely elevated total bilirubin results were obtained on five patient samples on a dimension vista 1500 instrument.The initial results were reported out to the physician(s), which were questioned.The customer repeated the same sample on an alternate dimension vista instrument, resulting lower.The customer repeated the same sample on the original instrument, resulting lower.Sample id (b)(6) did not have enough sample left, and was not repeated on the original instrument.The customer issued corrected reports.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.
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