Model Number I400+ |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer replaced the chloride electrode but noticed multiple bubbles in the electrode.The field service engineer was unable to determine a cause.He checked the mix/dry settings and pinch valves and performed calibrations that failed.He replaced the new chloride electrode with the customer's original electrode.Calibration, qc, and precision testing then passed.The investigation is ongoing.
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Event Description
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There was an allegation of questionable ise indirect gen.2 results from the cobas integra 400+ analyzer.Patient sample 1 initial sodium result was 151 mmol/l.The patient was sent to the er for a new sample to be drawn and the result was 144 mmol/l.The original sample was repeated on a cobas 6000 analyzer and the result was 143 mmol/l.Patient 2 initial sodium result was 149 mmol/l and the repeat result was 140 mmol/l.Patient 3 initial sodium result was 148 mmol/l and the repeat result was 140 mmol/l.The questionable results were reported outside of the laboratory.The repeat results were believed to be correct.The electrode lot number and the expiration date were requested but were not provided.
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Manufacturer Narrative
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The investigation determined the service actions of replacement of the chloride electrode resolved the issue.
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Search Alerts/Recalls
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