A customer from the united states observed a discordant ca 15-3 result on the advia centaur cp for one patient compared to a result on another advia centaur cp at an alternate site.All related quality control results were within the customer ranges.The customer states that the samples were not stored at room temperature for longer than 8 hours.The aliquots were put into pour over tubes with screw caps and immediately refrigerated within 8 hours of collection.The refrigerated samples were picked up the next day and run within 3 hours.The limitations section of the instructions for use states: note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.Siemens continues to investigate.
|
Initial mdr 1219913-2022-00148 was filed on 16-may-2022.Additional information: 23-may- 2022.A united states (us) customer did a split sample study comparing recovery at their site using advia centaur cp ca 15-3 kit lot 199 and calibrator lot c4369 vs recovery at another site using advia centaur cp ca 15-3 kit lot 199 and calibrator lot c4368.Recovery at the customer site varied from 4.30 - 22.5 u/ml and recovery at the other site varied from 6.10 - 36.6 u/ml with the average recovery being 30% higher at the other site.Siemens reviewed the calibration data provided and there is no evidence of a problem.Qc data provided for the customer site when the samples were tested show level 1 control recovery was in range, but low (16.3 u/ml vs a target of 18.7 u/ml, -13%) and even lower when compared to march unity data (19.5 u/ml, -16%).The customer declined service as the analyzer was undergoing preventative maintenance, no issues were noted with the analyzer.The customer declined running master curve materials (mcm) and declined further troubleshooting.A review of internal data indicates advia centaur cp ca 15-3 kit lot 199 and ca 15-3 calibrator lot c4369 are performing as intended.The cause of the difference in result seen by the customer when using advia centaur cp ca 15-3 kit lot 199 and calibrator lot c4369 as compared to other site could not be determined.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.In section h6, investigation finding, and investigation conclusion codes were updated based on additional information.
|