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Model Number FT4 G3 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Calibration and qc data were requested but not provided.The observed differences in ft4 values generated with the roche assay and siemens centaur assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.
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Event Description
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The initial reporter received a questionable elecsys ft4 iii assay result for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The customer¿s ft4 result was requested but not provided.The questionable result was reported outside the laboratory, which the physician asked for re-measurement of the sample.The patient¿s sample was provided for investigation and was tested on a cobas 8000 e 801 module, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The patient¿s sample was also outsourced and tested on a siemens centaur analyzer.Refer to the attachment on the medwatch for all patient data.
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Search Alerts/Recalls
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