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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 02/02/2016
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant advia centaur xp ca19-9 results with the alternate method is unknown. The instrument is performing within specifications. No further evaluation of the device is required. 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
Discordant high advia centaur xp ca 19-9 results were obtained for a patient sample. The initial result was high. The patient sample was diluted and repeated. The results were high. The patient sample was tested on another advia centaur xp and the result was high. The patient sample was tested on two alternate methods and the results were negative. There is no indication of a cancer diagnosis for this 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 1219913-2016-00029 on february 5, 2016. 02/09/2016 additional information: the age of the patient: (b)(6), patient identifier: (b)(6). The customer did not perform hbt (heterophillic blocking tube) and nabt (non-specific antibody blocking tube) testing. The customer does not have access to these tubes. The patient sample can not be sent to siemens healthcare diagnostics for further testing and investigation due to china's customs limitations. The difference in results between the advia centaur xp ca19-9 assay and the alternate method assays with this one patient sample is most likely due to some unknown interferent. The instrument is performing within specifications. No further evaluation of the device is required.
 
Manufacturer Narrative
Siemens filed the initial mdr 1219913-2016-00029 on february 5, 2016. Siemens filed the mdr 1219913-2016-00029 supplemental report 1 on february 11, 2016. On 02/15/2016 additional information: the customer diluted the patient sample manually and the diluted results are as follows: manual dilution ×5 3175. 85 u/ml, manual dilution ×10 3459. 6 u/ml, manual dilution ×25 3470 u/ml, manual dilution ×50 3467 u/ml, manual dilution ×100 3219 u/ml. The difference in results between the advia centaur xp ca19-9 assay and the alternate method assays with this one patient sample is most likely due to some unknown interferent. The patient sample is not available for further investigation. The instrument is performing within specifications. No further evaluation of the device is required.
 
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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 Key5413603
MDR Text Key37573779
Report Number1219913-2016-00029
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/16/2016
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 Received02/15/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/05/2015
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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