Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely elevated direct bilirubin (dbi) results.Hsc has reviewed the information provided and concludes that it is not a reagent lot or assay issue.Based on the information and data available, this event is isolated to a single well set (5;1) from flex sequence 1404 and not a reagent lot product problem.The customer has not observed falsely elevated dbi results from any other reagent flexes or well sets of this reagent lot number.The data file indicates an improper preparation of the diazotized sulfanilic acid in well 1.The reagent in well 1 is prepared automatically by the instrument.After loading a new reagent flex, patient and quality control dbi results returned to the laboratory expected values.There is no evidence of a product non-conformance.The cause of the event is unknown.No further evaluation is required.
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Discordant, falsely elevated direct bilirubin (dbi) results were obtained on pediatric patient samples on a dimension vista 500 system.The discordant results were reported to the physician who questioned the results.New samples were processed on an alternate dimension vista instrument and lower results were obtained.Corrected reports were issued.One patient (sample id (b)(6)) was treated for the elevated dbi result by having additional blood draws, being fed a special formula instead of breastmilk and having a liver ultrasound which gave a normal result.There were no adverse health consequences due to the discordant falsely elevated dbi results or due to the treatment.
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