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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 ASSAY 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 08/24/2016
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 has requested the patient sample for further testing and investigation. 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. " the ifu states in the limitations section: "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. ".
 
Event Description
A false positive advia centaur xp ca 19-9 result was obtained for a patient sample using reagent lot 380. The patient sample was tested on an alternate method and the result was negative. The negative result matched the clinical picture and the patient's historical result. The patient sample was tested on ca 19-9 reagent lot 382 on the advia centaur xp. The result was high. 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 1219913-2016-00165 on september 20, 2016. On 10/26/2016 additional information: the patient sample was not available for further testing and investigation. Therefore a cause could not be determined. Immunoassays are subject to a number of interferences including those caused by endogenous antibodies. Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies. Patients exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed. The interfering antibodies can give rise to a falsely high or less commonly a falsely low result. The erroneous result is recognized as being inconsistent with the patient's clinical picture. The laboratory procedures generally used to identify the presence of interfering antibody are serial dilutions to demonstrate a nonlinear response. Please note the interferent may not necessarily be due to an interfering antibody but may be due to other exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood. The cause for the ca19-9 discordant results is unknown. The instrument is performing within specifications. No further evaluation of the device is required. On 11/03/2016 correction: in the date received by the manufacturer was reported as 08/24/2016 and was incorrect. The correct date was 09/06/2016. The ifu states in the limitations section: "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. 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. ".
 
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Brand NameADVIA CENTAUR XP CA 19-9 ASSAY
Type of DeviceIMMUNOLOGICAL 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 Key5962847
MDR Text Key55128335
Report Number1219913-2016-00165
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K031393
Number of Events Reported1
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 11/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2016
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number380
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 Received10/26/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/21/2015
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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