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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CETNAUR XPT CA 19-9 IMMUNOASSAY 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 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
Siemens healthcare diagnostics is investigating. 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 of the instructions for use 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 ca19-9 can be observed in patients with nonmalignant diseases. Measurements of ca19-9 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 1219913-2019-00256 was filed for the same event for the advia centaur xpt ca19-9 initial result.
 
Event Description
A customer observed discordant high results for a patient between advia centaur xpt ca19-9 and an alternate testing platform. The initial result was reported and questioned by the physician. The sample was retested on the same advia centaur xpt on the same day and was also tested with an alternate method on the same day. A corrected report was issued based on the alternate method test result. All controls were in acceptable ranges. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca19-9 results.
 
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Brand NameADVIA CETNAUR XPT CA 19-9 IMMUNOASSAY
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 Key9416904
MDR Text Key208324417
Report Number1219913-2019-00266
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
Type of Report Initial,Followup,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2020
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number96919449
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 Received01/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2019
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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