Catalog Number 06437281190 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/12/2014 |
Event Type
malfunction
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Event Description
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The customer received questionable thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3) results for an unknown number of patient samples.The customer tested the patient samples on a cobas 8000 e602 analyzer.As part of the investigation, the samples were tested on a cobas e411 analyzer and a centaur analyzer (clia).Of the data provided for 12 patient samples, only the results for 11 patient samples were discrepant.Refer to the attachment to the medwatch for all patient data.Information concerning which result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.(b)(6).
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Manufacturer Narrative
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This event occurred in (b)(6).
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Manufacturer Narrative
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Six of the patient samples were submitted for further investigation and the customer's ft4 and ft3 results were reproduced.For sample 5, an interfering factor to streptavidin was found.This interference with the assay is documented in product labeling.
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Manufacturer Narrative
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The remaining five patient samples, were analyzed with and without the assay prewash and no difference was found between the results.Based on these results, an interfering factor to streptavidin was excluded.A specific root cause could not be identified for these samples.
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Search Alerts/Recalls
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