The customer obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant atellica im total hcg result.
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The customer from united states obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.The interpretation of results section of the atellica im total hcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.
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Initial mdr 1219913-2023-00036 was filed on (b)(6) 2023 reporting the united states customer obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.Additional information - mar 20, 2023.Sample and reagent trace files were not provided for sid# (b)(6) which resulted on (b)(6) 2023.Additional information - mar 31, 2023.The customer reported falsely elevated non-reproducible patient results on atellica im total hcg (thcg) reagent lot 346.The sample was tested on (b)(6) 2023.The sample was initially high at 389.6 miu/ml and repeated significantly lower at 2.6 miu/ml.The lower repeat values were believed to be accurate.Nothing abnormal was noted with the appearance of the sample.Thcg reagent lot 346 calibration was valid and biorad qc lot 85320 resulted within range on both days of testing.Service was also dispatched for this issue and a total service call was performed.The engineer replaced the wash ring ionizer but no other abnormalities were found.The customer continues to run thcg reagent lot 346 without any further concerns.Based on the available information, the cause of the discordant results is consistent with preanalytical variables and/or sample handling issues.No potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.
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