The investigation determined a non-reproducible, lower than expected vitro's phenytoin (phyt) result was obtained for a single patient sample when tested using vitro's chemistry products phyt slides lot 2620-0172-3383 on a vitro's 5600 integrated system.A definitive assignable cause could not be determined.Vitro's phyt within run precision testing using an alternate lot of reagent and diagnostic precision testing using vitro's crbm (carbamazepine) slides were performed by the customer on the vitro's 5600 integrated system.The testing yielded results that were within acceptable guidelines suggesting an instrument issue did not likely contribute to the event.Historical vitro's phyt quality control results indicate acceptable accuracy of vitro's phyt lot 2620-0172-3383, but unacceptable within laboratory precision.The within run phyt precision test suggests the unacceptable within laboratory precision is due to day to day fluid handling inconsistencies.Since the within run vitro's phyt precision test was performed using an alternate lot of vitro's phyt (lot 2620-0172-5478), vitro's phyt lot 2620-0172-3383 cannot be entirely ruled out as a contributor of the event.It is unknown if the customer processed the patient sample following recommendations by the device manufacturer.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this cannot be confirmed.
|
A customer obtained a non-reproducible, lower than expected vitros phenytoin (phyt) result from a single patient sample when tested using vitros chemistry products phyt slides lot 2620-0172-3383 on a vitros 5600 integrated system.Patient sample vitros phyt result of 8.0 ug/ml versus an expected vitros phyt of 34.1 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, lower than expected vitros phyt result was reported from the laboratory.However, no treatment was initiated, altered or stopped based upon the reported result.A corrected report was later issued.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).
|