MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 ASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp ca19-9 results with the alternate method is unknown. Siemens healthcare diagnostics is awaiting further information. The instrument is performing within specifications. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis. Do not predict disease recurrence solely on levels of advia centaur ca 19-9. Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease. Do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals. Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases. Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity. Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. Therefore, it is important to use assayspecific values to evaluate quality control results. ".

Event Description

A false positive advia centaur xp ca 19-9 result was obtained for a patient sample. The patient sample was tested on two alternate methods and the results were negative. The physician accepted the negative ca19-9 result after reviewing other tests for the patient. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00139 on august 5, 2016. On 08/17/2016 additional information: the customer provided the lot number used at the time of testing. Lot 382, expiration date: 01/09/2017. The patient was reported as healthy. The alternate method result was used. The pid is 854. The customer does not have any patient sample remaining for further testing and investigation. The customer is using a local blood collection tube and not from a registered manufacturer. Since the patient sample was not repeated with the advia centaur xp ca 19-9 assay, it is impossible to determine if the elevated result was due to the assay or some kind of sampling error. The cause for the discordant advia centaur xp ca19-9 results with the alternate methods is unknown. The instrument is performing within specifications. No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP CA 19-9 ASSAY
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5851427
• MDR Text Key: 51373047
• Report Number: 1219913-2016-00139
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2016
• 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