Catalog Number 07027397190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The customer received questionable thyroid results for one patient from cobas e 801 module (b)(4).The sample was repeated on a siemens analyzer.The initial elecsys ft4 ii assay result was 28.1 pmol/l and repeat result was 16.1 pmol/l.The initial elecsys tsh assay result was 1.28 miu/l and the repeat result was 2.56 miu/l.The initial elecsys ft3 result was 12.2 pmol/l and the repeat result was 4.7 pmol/l.This medwatch is for the ft4 assay.Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.
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Manufacturer Narrative
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Sample from the patient was submitted for investigation.The sample was found to contain an immunoglobulin that reacts with the reagent and affects the sample results.This interference is documented in product labeling for the assay.
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Search Alerts/Recalls
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