The investigation determined that higher than expected creatinine (crea) results were obtained when a vitros performance verifier (pv) fluid was processed using vitros crea slide lot 1536-3509-6781 on a vitros 350 chemistry system.The assignable cause of the event was not determined.However, user error with incorrect calibration programming is a contributing factor to the event.The customer used calibrator fluid from kit lot 110 but the analyzer was programmed with calibrator kit lot 178.Therefore, the incorrect bottle values were used when generating the calibration data and caused the suboptimal calibration and unacceptable quality control (qc) results.A recalibration was performed using the appropriate calibrator kit lot number in the calibration program and the qc results post calibration were still higher than expected.The customer had no other inventory on site for continued investigation and is waiting for new product.The investigation is ongoing.A review of the performance of the vitros pv controls on the previous vitros crea slide lot indicated acceptable performance and it was concluded that the vitros pv fluid lots were not a likely contributor to the issue.An instrument issue could not be confirmed or ruled out as a potential contributing factor as no diagnostic precision testing was performed to assess the performance of the analyzer.A complaint review was performed on this slide lot and there was no indication of a quality issue with vitros crea slide lot 1536-3509-6781.In addition, continual tracking and trending of complaints has not identified any signals that would point to a systemic issue with vitros crea slide lot 1536-3509-6781.Email address for contact office above is (b)(6).
|
A customer obtained higher than expected creatinine (crea) results when a vitros performance verifier (pv) fluid was processed using vitros crea slide lot 1536-3509-6781 on a vitros 350 chemistry system.Vitros pv1, lot u8105 results of 1.84, 2.0, 1.85, 1.87, 1.84 and 2.0 mg/dl versus the expected result (baseline mean) of 0.99 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros crea results were obtained when the customer was processing a non-patient fluid.However, the investigation cannot confirm that patient results would not be affected if the event were to recur undetected.There have been no allegations of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).This report is number one of six 3500a forms filed for this event, as six devices were affected.
|