Catalog Number K1023 SMN 10445160 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis of the instrument and instrument data indicates that the cause for the falsely depressed ca patient results is unknown.Siemens healthcare is investigating calcium (ca) lot 16109bb.The mdr will be updated with the results of the investigation.
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Event Description
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Falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista flex(r) instrument.Patient results were reported to physicians.The samples were repeated on the alternate vista instrument and higher results were obtained.Corrected results were issued.There is no indication that patient treatment was altered or prescribed on the basis of discrepant ca results.There was no report of adverse health consequences as a result of discrepant ca results.
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Manufacturer Narrative
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Original mdr 2517506-2016-00282 was filed july 15, 2016.A siemens customer service engineer (cse) was dispatched to the site.The cse cleaned and tested the reagent mixer and aligned probes.Mix testing and the probe test passed after these procedures were performed.The instrument was calibrated by the customer and function validated with qc within laboratory ranges.The instrument was deemed to be fully functional upon departure.The siemens headquarters support center (hsc) specialist reviewed the instrument data and concluded their investigation.Limited information was available pertaining to pre-analytical specimen handling and centrifugation practices.The root cause of the discordant low calcium (ca) results is unknown but the issue has been resolved by the service.The instrument is performing according to specifications.No further evaluation of the device is required.
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Search Alerts/Recalls
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