The customer observed falsely elevated ca19-9 results while using the architect ca 19-9xr reagents.The following data was provided.Initial 551.01 u/ml, repeat 14.13, 15.12 u/ml.The customer stated that no abnormal ultrasound findings were observed for the patient.It is unknown if the patient was being monitored for pancreatic cancer.No adverse impact to patient management was reported.
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Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, and field data review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The product was not available for return.Review of field data showed that the patient median result for complaint lot 74019m800 is within the established control limits and no unusual reagent performance was observed.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.
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