A customer obtained higher than expected vitros tsh results from an institute for quality management in healthcare (iqmh) proficiency fluid when tested using two different lot of vitros tsh reagent on a vitros 5600 integrated system.The cause of the higher than expected vitros tsh results cannot be determined.Historical vitros tsh lot 5900 quality control results indicate acceptable performance.However, the customer does not process a designated tsh quality control fluid at a similar concentration as the proficiency fluid.In addition, the customer obtained an acceptable tsh result when processing the fresh proficiency sample using a different vitros tsh lot, therefore a reagent issue involving vitros tsh lot 5900 cannot be ruled out as a contributor of the event.Furthermore, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tsh reagent lot 5900 or vitros tsh reagent lot 5945.A within run tsh precision test was not performed at the time the proficiency sample was processed to evaluate the performance of the vitros 5600 system.However, historical quality control results do not indicate an issue with precision therefore a vitros 5600 system issue is not a likely contributor of the event.The customer did not provide sample handling details.It is possible the customer did not handle the vial 1 sample as per the proficiency suppliers¿ instructions.The customer obtained a similar result when reprocessing the sample, therefore a sample related issue cannot be ruled out as a contributor of the event.
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A customer obtained higher than expected vitros tsh results from an institute for quality management in healthcare (iqmh) proficiency fluid when tested using two different lots of vitros tsh reagent on a vitros 5600 integrated system.Iqmh 1009-1 (sample 1), vitros tsh lot 5900 results of 0.28, and 0.24 miu/l versus the expected vitros tsh result 0.12 miu/l.Iqmh 1009-1 (sample 2), vitros tsh lot 5945 result of 0.18 miu/l versus the expected vitros tsh result 0.12 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros tsh results were obtained when the customer was processing non-patient fluids.However, the investigation cannot confirm that patient sample results were not affected or would not be affect if the results were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).
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