The investigation determined that a non-reproducible, higher than expected sodium (na+) result was obtained from a single patient sample processed using vitros na+ slides lot 4208-1093-4724 on a vitros 4600 chemistry system.The assignable cause of the event is unknown.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer's recommended centrifugation protocol.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 could not be confirmed.Based on historical quality control results, a vitros na+ lot 4208-1093-4724 performance issue is not a likely contributor of the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4208-1093-4724.Diagnostic precision testing was within expectation, indicating that an issue with the vitros 4600 chemistry system was not a likely contributor to the event.
|
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected sodium (na+) result was obtained from a single patient sample processed using vitros na+ slides lot 4208-1093-4724 on a vitros 4600 chemistry system.Vitros na+ patient result of 156 mmol/l versus the expected (repeat) result of 129 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected patient sample result was not reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
|