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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 Problems High Test Results (2457); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant ca19-9 results is unknown. Siemens healthcare diagnostics is investigating. 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. " mdr 1219913-2020-00023 was filed for the same event for advia centaur xp #1 result.
 
Event Description
Two discordant high results were obtained on one patient sample with the advia centaur xpt ca19-9 immunoassay. The patient sample was tested on two advia centaur xp systems and similar high results were obtained between the systems. The results were reported to physician and questioned. A new sample from the same patient was obtained at a later date and tested with atellica im ca19-9 immunoassay on two systems. Lower results were obtained on both systems. A corrected report was issued with the lower results. Quality control was within specification for all systems used for testing. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant high ca19-9 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 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
stacy loukos
333 coney street
east walpole, MA 02032
5086608576
MDR Report Key9612375
MDR Text Key195110729
Report Number1219913-2020-00024
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeMY
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
Report Date 04/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2020
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 Number052452
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 Received04/02/2020
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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