Catalog Number DF 167 SMN 10444957 |
Device Problems
High Test Results (2457); Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed and falsely elevated total bilirubin (tbi) results.Hsc analysis of the instrument photometer data indicates the patient samples identified as the "neat" undiluted sample by the customer were actually the diluted sample.Conversely, patient samples identified by the customer as the diluted sample were actually the "neat" undiluted sample.Hsc concludes the cause of the discordant tbi results was due to the use error of switching the order of the "neat" undiluted sample with the diluted sample in the segment locations on the instrument.Hsc has reviewed the information provided and concludes that it this event was not a reagent lot issue or an assay issue.There is no evidence of a product nonconformance.The device is performing within specifications.No further evaluation of the device is required.
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Event Description
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Discordant, falsely depressed and discordant falsely elevated total bilirubin (tbi) results were obtained on a patient sample on the dimension exl system.The discordant results were not reported to the physician.The same samples were reprocessed the same day and a correct result was obtained.The correct result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed and falsely elevated tbi results.
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Search Alerts/Recalls
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