Catalog Number K1137 SMN 10445163 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Mdr 2517506-2019-00410 was also filed for the same event.The customer contacted the siemens customer care center (ccc) and reported a discordant depressed carbon dioxide (co2) patient result was obtained on a dimension vista 500 instrument.Siemens healthcare diagnostics headquarters support center (hsc) is investigating the event.
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Event Description
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A discordant falsely depressed carbon dioxide (co2) patient result was obtained on a dimension vista 500 instrument.The initial result was reported to the physician(s) who questioned the result.The same sample was reprocessed at an alternate facility on an alternate dimension vista instrument and the original low result was confirmed.A new patient sample was drawn at an alternate facility and processed on a later date on a non-siemens blood gas analyzer methodology and a higher correct result was obtained and reported.There are no reports of patient intervention or adverse health consequence due to the discordant falsely depressed co2 result.
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Manufacturer Narrative
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Mdr 2517506-2019-00412 was filed on 25-oct-2019.Mdr 2517506-2019-00410 was filed for the same event.Additional information (24-oct-2019): the customer confirmed that a result of <5 mmol/l was obtained on a non-siemens alternate enzymatic co2 methodology for patient sample identification numbers (sids) 1306851 and 1307434.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed carbon dioxide (co2) results.Hsc evaluated the information provided and the instrument data files.Samples from the patient were provided.Siemens technical support laboratory (tsl) internal testing of the samples was inconclusive for the cause of the depressed dimension vista co2 results.No product problem was identified.The cause of this event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.
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Search Alerts/Recalls
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