Catalog Number 11416755 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/08/2021 |
Event Type
malfunction
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Event Description
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The customer reported discrepant potassium results from one patient on the rp 500e when compared to the rp 500 and another siemens lab analyzer.There is no report of injury due to this event.
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Manufacturer Narrative
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Siemens has requested and received the paz and r1 files for investigation.The customer stated the instrument is operational.The cause of this event is unknown.
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Event Description
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The customer reported discrepant potassium results from one patient on the rp 500e when compared to the rp 500 and another siemens lab analyzer.There is no report of injury due to this event.
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Manufacturer Narrative
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Siemens has requested and received the paz and r1 files for investigation.The customer stated the instrument is operational.The cause of this event is unknown.
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Manufacturer Narrative
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Siemens has completed the investigation of the instrument files.The instrument and k+ sensor in the m-cart were working as intended in and around the time of the reported discrepant results based on the sensor's slope and calibration stability, recovery of aqc.The rp500e sn (b)(6) results from the patient sample appear valid.The elevated rp500e k+ value reported on (b)(6) 2021 at 12:59 appears to be due to potassium supplement that the patient received as a part of treatment.The rp500 result was obtained 1 hour prior to the alleged elevated k+ result on rp500e.A duration of 1 hour is sufficient for a patient k+ whole blood values to increase since the patient was given potassium supplement.
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Search Alerts/Recalls
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