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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP CA 19-9 IMMUNOASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN Back to Search Results
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.
 
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Brand NameADVIA CENTAUR CP CA 19-9 IMMUNOASSAY
Type of DeviceIMMUNOLOGICAL 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 Key5427463
MDR Text Key37989155
Report Number1219913-2016-00025
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K031393
Number of Events Reported1
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 Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2016
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number052374
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 Received04/05/2016
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

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