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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Customer observed high advia centaur cp br (assay for ca 27.29) results which failed the customer's delta check.The results were lower upon repeat testing.No results were reported and no corrected reports were sent out.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp br results.

Manufacturer Narrative

Upon investigation of the delta check failure for patient sample results generated with advia centaur cp br (ca 27.29 assay), the customer noted that there was excess calibrator left in the calibrator vials used to perform several calibrations of the assay.Customers are instructed to reconstitute calibrator g with 2 ml of di water.The customer feels that the calibrators were reconstituted with 5 mls of di water instead of 2 mls.Once the fresh vials of calibrators were reconstituted with the correct volume of di water, quality control results were within range.The system is performing within specification.No further investigation is required.The limitation section of the instructions for use states: "warning: do not use the advia centaur cp br assay as a screening test or for diagnosis.Normal levels of ca 27.29 do not always preclude the presence of disease.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 the patient's clinical evaluation.".

• Brand Name: ADVIA CENTAUR CP BR (ASSAY FOR CA 27.29)
• Type of Device: CA 27.29 ANTIGEN IMMUNOASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 4273847
• MDR Text Key: 5003633
• Report Number: 1219913-2014-00282
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2015
• Device Model Number: N/A
• Device Catalogue Number: 03896216
• Device Lot Number: 047210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• 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