The investigation determined that a higher than expected bhcg ii result was obtained from non-vitros biorad l1 qc fluid lot 85231 using vitros immunodiagnostics products bhcg ii reagent lot 2840 in combination with a vitros 5600 integrated system.The assignable cause for the higher than expected vitros bhcg qc fluid results could not be determined with the information provided.Based on historical quality control results, a vitros bhcg lot 2840 performance issue is not a likely contributor to the event.Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event as inspection of the instrument by an ortho field engineer concluded the vitros 5600 integrated system was fully operational.Sample handling could not be ruled out as a possible cause of the higher than expected results as the customer was only allowing 15 minutes before loading on the instrument following removal from the refrigerator.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg ii reagent lot 2840.(b)(4).
|