Catalog Number 09315322190 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the e602 analyzer is (b)(6).Calibration and controls were acceptable.The investigation is ongoing.
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with elecsys troponin t hs on a cobas 8000 e 602 module.The sample initially resulted in a troponin t value of 13.41 ng/l.The sample was repeated twice on a second analyzer, resulting in troponin t values of 265 ng/l and 264 ng/l.
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Manufacturer Narrative
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The field service engineer found the sample probe tip was dirty and covered in dried serum.He also noticed a black unknown substance came out of the probe.He replaced the probe.Based on these findings, the investigation determined the issue was due to pre-analytical handling issues at the customer site and insufficient user maintenance.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.A general reagent problem was not present, because the qc before the event was within ranges.
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Search Alerts/Recalls
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