MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP 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 Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

A falsely low advia centaur xp br (assay for ca 27.29) dilution result was obtained by the customer on a patient sample and was considered discordant when compared to the over assay range neat result.An auto dilution of the patient sample was run and the result was over-dilution.The customer performed a manual dilution that was repeated with fresh multi-diluent 1 and the results were low.The neat sample was repeated and the br result was over the assay range upper limit.The customer performed serial dilution testing on the patient sample and observed low results.The patient sample was treated with heterophile blocking tubes (hbt) and nonspecific binding tubes and the br results were elevated.There is no known report of adverse health consequences due to the discordant lower advia centaur xp br (assay for ca 27.29) dilution results.

Manufacturer Narrative

The cause for the falsely low advia centaur xp br (assay for ca 27.29) dilution results when compared to the over assay range neat result and the elevated results when the patient sample was treated with heterophile blocking tubes (hbt) and nonspecific binding tubes may be attributed to an interfering substance.The customer's quality control results were within acceptable ranges and there were no other discordant br results reported by the customer for the advia centaur xp br (ca 27.29) assay at the time of the event.The limitations section of the instructions for use states the following: "warning do not use the advia centaur br assay as a screening test or for diagnosis.Normal levels of ca 27.29 do not always preclude the presence of disease.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required.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." the instrument is operating within specification.

• Brand Name: ADVIA CENTAUR XP 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: 3651712
• MDR Text Key: 4199702
• Report Number: 1219913-2014-00068
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• 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: 02/04/2014
• 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