Catalog Number 10697306 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2018 |
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 customer has changed the measurement cartridge.Siemens has requested the r1 files for investigation.Siemens service went on site and the service report is pending.The root cause for the discrepant results is unknown.
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Event Description
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The customer reported discrepant total hemoglobin results on two patients between two rp 500 analyzers.There was no report of injury due to this event.
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Manufacturer Narrative
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Changed "date of event" to (b)(6) 2018.Manufacturer narrative: the customer stated that the r1 files are not available.Siemens reviewed the event log and there are no persistent sensor errors or system errors for this cartridge.Siemens service went onsite and changed the connector block and then replaced the cartridge interface frame (cif).The system is operational.
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Search Alerts/Recalls
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