MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP CA 15-3

Model Number	N/A
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer 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 another site.It is unknown which result is correct.The initial result was reported to the physician and was not questioned.There are no reports that treatment was altered or prescribed due to the discordant advia centaur cp ca 15-3 result.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.

• Brand Name: ADVIA CENTAUR CP CA 15-3
• Common Device Name: CA 15-3
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 14417903
• Report Number: 1219913-2022-00148
• Device Sequence Number: 17544372
• Product Code: MOI
• UDI-Device Identifier: 00630414461311
• UDI-Public: 00630414461311
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2022
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 199
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown