Mdr was filed reporting that the customer observed elevated ca 19-9 results on the advia centaur cp and the advia centaur xp compared to two alternate methods.Additional information - may 17, 2019.The customer provided the diluted results for this sample on the advia centaur cp ca 19-9.The results were 273.76(1:2), 315.68(1:4) and 403.04(1:8).Non-linear dilutions are consistent with potential heterophilic antibody interference.Siemens is not able to confirm heterophilic interference because the sample cannot be returned for analysis.The limitations section of the instructions for use states: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." no further investigation is required.Mdr 1219913-2019-00068 and mdr 1219913-2019-00068 supplemental 1 were filed for advia centaur cp ca 19-9 result 465.76 u/ml.
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