Model Number 10321852 |
Device Problem
Non Reproducible Results (4029)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2020 |
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.No patient treatment was affected due to the discrepant results.Siemens has requested instrument log files for investigation.The cause of this event is unknown.
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Event Description
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The customer reported several discrepant thb results on their rl1265 instrument compared to retesting of different samples on a non-siemens hematology instrument.There is no report of injury due to this event.
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Manufacturer Narrative
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The customer was not able to provide instrument files.Without files, siemens cannot perform a proper investigation and therefore the root cause of the customer issue cannot be determined.Siemens has provided the customer with instrument comparison studies and service has reiterated the importance of sample handling.The customer has declined to perform their own internal correlation study for siemens to evaluate.However, they have accepted the recommendations for sample handling and pre-analytics.The cause of this event is unknown.
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Search Alerts/Recalls
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