The investigation determined that higher than expected vitros amon results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system.The assignable cause of the event cannot be determined with the information provided.Historical qc for vitros amon lot 1018-0255-4508 was unacceptable, however a complaint review for vitros amon lot 1018-0255-4508 indicated only one additional complaint that was resolved by service actions.Continual tracking and trending does not indicate a systemic issue with vitros amon lot 1018-0255-4508.A diagnostic vitros amon precision test was requested by the tsc but not completed by the customer at the time of this report.Therefore, an issue with the vitros 5600 integrated system cannot be ruled out as a contributor to the event.(b)(4).
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The investigation determined that higher than expected vitros ammonia (amon) results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system.Biorad lot 54302 vitros amon results of 108.4, 104.4, 108.9, 118.5, 92.1, 99.5 and 90.4 umol/l versus the baseline mean of 74.76 umol/l the customer obtained the lower than expected result when processing a non-patient fluid.There was no indication patient results were affected around the time of the event.However, the investigation could not rule out patient samples would not be affected if the event were to recur undetected.Ortho was not made aware of any allegation of patient harm as a result of this event.This report is number seven of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
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