Catalog Number 08056960190 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The investigation is ongoing.
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Event Description
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There was an allegation of questionable bilt3 bilirubin total gen.3 results for 1 patient sample on a cobas c 503 analytical unit.This medwatch will cover bilt3.Refer to medwatch with a1 patient identifier (b)(6) for information on the dbili results and medwatch with a1 patient identifier (b)(6) for information on the albp results.On (b)(6) 2023, the initial bilt3 result was 28.9 umol/l.The repeat bilt3 result was 18.6 umol/l.
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Manufacturer Narrative
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Section d product information has been updated, as well as g1 manufacturing site and g4.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
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Search Alerts/Recalls
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