Catalog Number 10697306 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.The data files have been requested for investigation.The cause of this event is unknown.
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Event Description
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The customer reported discrepant total hemoglobin results when tested on the rp 500 and a non-siemens lab analyzer.There was no report of injury due to this event.
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Manufacturer Narrative
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Siemens evaluated the data provided by the customer.Review of the rp 500 s/n (b)(4) data files do not indicate any performance issues with the thb assay.There are known differences between the methodologies and matrices of the laboratory systems and blood gas systems which can influence results.Thorough and often mixing of whole blood is essential for accurate thb measurements.Method comparison(s) of the systems could identify any specific trend(s) between the lab methodologies and the poc units.A review of the escalated samples indicate there were no results flagged as questionable and there were no reported thb calibration drift errors around the time of the events.The aqc results were in the expected ranges.There were no unusual optical errors to indicate any co-ox performance issues.This along with aqc recovery indicates that the optical functionality was performing as intended.The cause of this event is unknown.
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Search Alerts/Recalls
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