Model Number 44052 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Information (3190)
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Event Date 10/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Results received from lab at 16:15 which indicated the patient should not have received contrast dye for the ct scan.Creatinine test strip lot passed qc testing.Patient had hematocrit of 27.5% which is contraindicated per label copy (hct range 30-60%).Creatinine interferences: "the creatinine meter exhibits no interferences in blood specimens with hematocrits from 30% to 60% or with varying oxygen content.".
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Event Description
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Facility stated they received a false creatinine value on the stat sensor meter.
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Manufacturer Narrative
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The customer complaint could not be confirmed.The alleged deficiency of discrepant results could not be reproduced.The performance of nova stat sensor creatinine test strip lot #4916098249 passes all acceptance criteria for linearity solutions and blood samples.Results for linearity solutions are within linearity solution ranges and there were no discrepancies observed between the results by retained nova stat sensor creatinine test strip lot 4916098249 and the rxl chemistry analyzer.There were no discrepancies observed between the results of the twenty five(25) returned nova stat sensor creatinine test strip lot #4916098249 and the rxl chemistry analyzer.
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Search Alerts/Recalls
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