• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 09/15/2015
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant advia centaur xp ca19-9 results is unknown. The customer no longer has the ca19-9 diluent that was used to dilute the two samples. The customer also stated that the ca19-9 diluent is used for the manual 1:10 offline dilutions. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the limitations section: "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. Furthermore, patients known to be genetically negative for the lewis blood group antigens will be unable to produce the ca 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the lewis blood group antigen may be insufficient to detect true lewis antigen negative individuals. Even patients who are genotype positive for the lewis antigen may produce varying levels of ca 19-9 as the result of gene dosage effect. 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. Warning: this device is not indicated for screening or the early detection of pancreatic cancer or as a diagnostic tool to confirm the presence or absence of malignant pancreatic disease. 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. ".
 
Event Description
Discordant advia centaur xp ca 19-9 results were obtained for samples from two patients when diluted. The difference in results was a ten fold increase. The initial results were reported. The result for patient 1 was questioned by the physician as the result was not expected for this patient. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant ca 19-9 results.
 
Manufacturer Narrative
03/11/2016 additional information: the customer sent in the second draw from patient 2 for further testing and investigation. The patient sample was run neat and diluted with ca19-9 lot 374. Ca19-9 results (u/ml) neat result: >700; 1:200 dilution result: 92,127. There was not enough volume of the patient sample to be tested for interference. The cause for the discordant advia centaur xp ca19-9 results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5466408
MDR Text Key39250201
Report Number1219913-2016-00045
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number372
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 Received03/11/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-