The investigation concluded that multiple lower than expected myog quality control results were obtained using a single non-vitros quality control level in combination with a vitros 5600 integrated system.A definitive assignable cause for the event could not be determined.Within run vitros tt4, tsh and myog precision tests, used to assess instrument function, were completed successfully.However, the instrument reported condition codes during the testing, therefore the vitros 5600 system could not be entirely ruled out as a contributing factor.Based on historical quality control results, a vitros myog reagent performance issue could not be ruled out as a contributor to the event.
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The customer observed multiple lower than expected vitros myog results obtained from a single non-vitros biorad quality control fluid processed on a vitros 5600 integrated system.Biorad l1 control results of 101.788, 110.53, 114.224, 95.95, 100.705, 100.142, 102.329, 101.235, 99.3981, 110.169, 113.515, 97.6875, 111.06 and 113.39ng/ml versus customer's established mean 124.90 ng/ml.A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples.Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the event, however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.(b)(4).
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