The investigation determined that higher than expected bhcg ii results were obtained from non-vitros seronorm l1 qc fluid lot 1709896 using vitros immunodiagnostics products bhcg ii reagent lot 2680 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 2680 performance issue is not a likely contributor to the event.Additionally, there is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the events as precision testing performed on the instrument was within ortho guidelines.Sample handling could not be ruled out as a possible cause of the higher than expected results as the customer was only allowing 5 minutes before loading on the instrument following removal from the refrigerator per the vitros bhcg instructions for use, you should bring samples to room temperature 15¿30 °c (59¿86 °f) before use.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systemic issue with vitros bhcg ii reagent lot 2680.
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A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected bhcg ii results obtained from a non-vitros seronorm l1 quality control (qc) fluid, using vitros immunodiagnostics product total b-hcg ii (bhcg) reagent on a vitros 5600 integrated system.Seronorm l1 qc fluid lot 1709896: 12.09 and 9.09 miu/ml versus expected result of 6.00 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros bhcg results were from non-patient fluid.The customer did not give any indication that patient results had been affected.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There is no allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).
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