The cause of the non-reproducible falsely elevated advia centaur cp total human chorionic gonadotropin (thcg) result is being investigated by siemens.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) under the limitation section states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." "there are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory." "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results sometimes in consultation with other medical experts.".
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Mdr 1219913-2018-00305 was filed on december 18, 2018 reporting that a customer observed an initially elevated advia centaur cp total hcg (thcg) result that did not repeat.January 3, 2019 - additional information: a customer service engineer went on site and aligned the probe as part of routine troubleshooting.No further issues were identified and the instrument is fully operational.The customer is satisfied with the performance of the assay and the system.
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