The investigation determined that a lower than expected vitros k+ results were obtained from a vitros quality control sample when processed on a vitros 5600 integrated system.A definitive assignable cause was not identified; however, two separate sub-optimal calibration events are the most likely contributing factors.An unexpected vitros instrument issue cannot be ruled as contributing to the event, as no within-run precision testing was performed to verify the system.A definitive assignable cause to the event cannot be identified.
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Multiple lower than expected vitros k+ results were obtained from a vitros performance verifier (pv) fluid sample (lot k4852) when processed on a vitros 5600 integrated system.The following results breached vitros k+ potential health and safety criteria: vitros pv ii vitros k+ results of 4.77, 4.76, 4.86, 4.70, 4.74, 4.72 4.69 4.70 4.73 and 4.70 mmol/l versus the expected result of 5.60 mmol/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action if the event were to occur with patient samples.There were no reports that unexpected patient sample results were reported outside the laboratory.However, the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report is number eight of ten 3500a forms filed for this event, as ten devices were affected.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).
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