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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 IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2020
Event Type  malfunction  
Manufacturer Narrative
The maintenance on the advia centaur xp system was up to date. Siemens healthcare diagnostics is investigating the cause of the discordant ca19-9 results. 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. 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
A falsely elevated advia centaur xp ca 19-9 result was obtained for a patient sample. The laboratory ran this patient sample through heterophilic antibody blocking tubes and the result was lower. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca 19-9 results.
 
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Brand NameADVIA CENTAUR XP CA 19-9
Type of DeviceIMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown, ny
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
e. walpole, ma
Manufacturer Contact
eiman sulieman
333 coney street
e. walpole, ma 
6604603
MDR Report Key9764200
MDR Text Key193331967
Report Number1219913-2020-00080
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeHU
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
Type of Report Initial,Followup,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2020
Device Model NumberN/A
Device Catalogue Number10491379
Device Lot Number36973452
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 Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2019
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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