Model Number FT4 G3 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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For 1 event, the investigation could not identify a product problem.The cause of the event could not be determined.For 1 event, the investigation is ongoing.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events.Questionable non-reproducible elecsys ft4 iii assay results were generated by a cobas 8000 e 602 module and a cobas 6000 e 601 module.The events involved a total of 14 patients.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.
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Manufacturer Narrative
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For one pending event: the investigation determined one level of calibrator had a very high signal on the calibration that had been performed.An issue with the calibrator is suspected.The calibration did not fail because there is no upper limit existing for calibration acceptance.Only one level of control was measured and no controls covering the lower end of the measuring range were measured.The issue with calibration would have been detected had a lower level of control been tested.There were no follow up actions for this event.
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Search Alerts/Recalls
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