Catalog Number 08057800190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); 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 11/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the c 503 analyzer is (b)(6).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 glucose hk gen.3 on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in a glucose value of 19.7 mg/dl.The value did not agree with the patient's clinical status, so it was repeated.The sample was repeated on a second analyzer, resulting in a glucose value of 99.9 mg/dl.The repeat value was deemed correct as it matched the patient's clinical status.
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Manufacturer Narrative
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The field service engineer checked the main pump and gear pump pressures.The rinse volume and probe condition were also checked.Precision studies were performed and were acceptable.Hardware performance testing passed.The investigation could not identify a product problem.The cause of the event could not be determined.The issue was resolved after the service actions.
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Search Alerts/Recalls
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