MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP CA 19-9 IMMUNOASSAY 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 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens investigated the issue at the local level by testing a diluted sample on an advia centaur system. Similar results were obtained. Siemens continues to investigate the issue. The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the limitations section states: "warning - 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. Note 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 assay specific values to evaluate quality control results. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. (9) 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 for diagnosis. ".

Event Description

Customer observed advia centaur cp ca 19-9 results that did not match diluted test results. The doctor questioned the results. There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur cp ca 19-9 results.

Manufacturer Narrative

Mdr 1219913-2016-00025 was filed on january 22, 2016 reporting advia centaur cp ca 19-9 results that did not match diluted test results. April 5, 2016 - additional information: siemens performed a 1/10 and 1/100 dilution of a patient sample with ca 19-9 diluent lot 3366. The neat result was >700 u/ml and the diluted results were 1328 u/ml and 1383 u/ml respectively. This indicates that there is not a systemic issue with the ca 19-9 diluent lot 3366. The complaint database was reviewed for other complaints related to ca 19-9 diluent lot 3366 and no other complaints were identified. This indicates that there could have been an issue with the shipping or handling of the diluent which the customer was using.

• Brand Name: ADVIA CENTAUR CP CA 19-9 IMMUNOASSAY
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• 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: 5427463
• MDR Text Key: 37989155
• Report Number: 1219913-2016-00025
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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

• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/06/2016
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 052374
• 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: 04/05/2016
• 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