Model Number BILT 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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The investigation for this event has not been completed.The follow up/corrective actions for this event have not been provided.No devices were returned.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 1 malfunction event.Non-reproducible results were generated by the cobas c 111.The event involved a total of 2 patients tested for bilt3 bilirubin total gen.3.
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Manufacturer Narrative
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The investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for this event.
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Search Alerts/Recalls
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