MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP BR (ASSAY FOR CA 27.29); CA 27.29 ANTIGEN IMMUNOASSAY, PRODUCT CODE:

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

Falsely low advia centaur cp br (assay for ca 27.29) results were obtained by the customer on four patient samples and they were considered discordant when compared to higher test history results.The patients are undergoing chemotherapy and the lower br (assay for ca 27.29) results were questioned by the physician.There is no known report of adverse health consequences due to the discordant lower advia centaur cp br (assay for ca 27.29) results.

Manufacturer Narrative

The cause for the falsely low advia centaur cp br (assay for ca 27.29) results when compared to higher test history results is unknown.The customer's quality control results were within acceptable ranges and the customer did not observed any other discordant results for other advia centaur cp assays that were being run at the time.No conclusion can be drawn.The limitations section of the instructions for use states the following: "note do not interpret levels of ca 27.29 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27.29 within the range observed in healthy individuals.Additionally, elevated levels of ca 27.29 can be observed in patients with nonmalignant diseases.Measurements of ca 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

• Brand Name: ADVIA CENTAUR CP BR (ASSAY FOR CA 27.29)
• Type of Device: CA 27.29 ANTIGEN IMMUNOASSAY, PRODUCT CODE:
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 3549036
• MDR Text Key: 4213666
• Report Number: 1219913-2013-00322
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/13/2013
• Device Model Number: N/A
• Device Catalogue Number: 03896216
• Device Lot Number: 047207
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1