Catalog Number 03337154001 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The event occurred in: (b)(6).
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Event Description
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The customer complained of multiple questionable total hemoglobin (thb) results when comparing the results from a cobas b 123 system and a cobas b 221 analyzer.From the thb data provided for 5 patients, 1 had discrepant results that were a reportable malfunction.This medwatch will cover the cobas b 221 (roche omni s) analyzer.Refer to the medwatch with patient identifier (b)(6) for information on the cobas b 123 system.The thb result from the cobas b123 was 138.8 g/l.The thb result from the cobas b221 was 107.3 g/l.It was unknown if the erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.
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Manufacturer Narrative
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Qc recovered within acceptable range on the day of the event.The investigation did 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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