Catalog Number 09038078160 |
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 05/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Na h3 other text : na.
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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 vitamin d total iii on cobas e411 rack analyzer serial number (b)(6).The patient sample initially resulted in a vitamin d value of 19.36 ng/ml and this value was reported outside of the laboratory.The sample was repeated, resulting in a value of 29.45 ng/ml.The repeat value was deemed correct.
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Manufacturer Narrative
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Calibration signals recovered within expectations and quality controls recovered within range.Upon review of the alarm trace, insufficient sample volume and clot pipetting errors were observed.These can indicate a potential sample quality issue.The field service engineer could not find any hardware issues.The probe alignments were adjusted.The liquid level detection voltage was checked and was within specifications.Performance testing passed.The investigation could not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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