Catalog Number 03003523001 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The field service engineer determined the issue was caused by a defective chloride electrode.The analyzer was checked.The electrode was replaced by the customer and the issue was resolved.
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with the chloride electrode on a cobas integra 400 plus (serial number (b)(4)).The sample initially resulted in a chloride value of 142 mmol/l and this value was reported outside of the laboratory.The sample was repeated, resulting in a value of 115 mmol/l.The repeat value was deemed correct and a corrected report was issued.
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Manufacturer Narrative
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Upon customer inspection of the affected electrode, the customer stated they saw something inside the electrode that looked like fungus.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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