Catalog Number 08058016190 |
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 12/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the customer's (b)(6) analyzer is (b)(6).The investigation is ongoing.
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Event Description
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The customer alleged they received discrepant results for two patient samples tested with the magnesium reagent on a cobas c 303 analytical unit.The initial values were reportedly questioned by the customer and the samples were repeated.The repeat values were deemed correct by the customer.The first sample reportedly resulted in an initial magnesium value of 2.0 mg/dl and it repeated as 1.1 mg/dl.The second sample reportedly resulted in an initial magnesium value of 2.6 mg/dl and it repeated as 1.8 mg/dl.
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Manufacturer Narrative
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The field service engineer could not determine a cause.The engineer programmed carryover evasion washes on the analyzer for magnesium testing.Instrument checks passed.Precision studies were performed.No further issues occurred.Calibration data was acceptable.Quality controls recovered within established ranges.There was no indication of a reagent or instrument performance issue.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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