• 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 09/09/2016
Event Type  malfunction  
Manufacturer Narrative
The cause of the elevated advia centaur xp ca 19-9 results is unknown. Siemens has requested the sample for further investigation. The limitations section of the instructions for use (ifu) states the following: "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. ".
 
Event Description
Customer observed elevated advia centaur xp ca 19-9 results on two samples from the same patient compared to results from an alternate laboratory. The elevated results did not agree with the clinical picture. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ca 19-9 results.
 
Manufacturer Narrative
Mdr 1219913-2016-00226 was filed on (b)(6) 2016 listing the type of report (section g7) as a 5-day report. The report should have been filed as an initial report.
 
Manufacturer Narrative
Mdr 1219913-2016-00226 was filed on november 23, 2016 reporting elevated advia centaur xp ca 19-9 results on two samples from the same patient compared to results from an alternate laboratory. The elevated results did not agree with the clinical picture. A supplemental report was filed on november 23, 2016 with a correction to the report type. December 19, 2016 siemens requested the samples for additional investigation, however, the samples were not available. No additional investigation can be performed since the samples are not available. Based on the available information, this is a sample specific issue and the advia centaur xp ca 19-9 assay is performing as intended. Additionally, it was noted, the patient is being monitored for ovarian cancer.
 
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.
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC
333 coney street
east walpole MA 02032
Manufacturer Contact
louise mclaughlin
333 coney street
east walpole, MA 02032
5086604381
MDR Report Key6124363
MDR Text Key60787207
Report Number1219913-2016-00226
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2017
Device Model NumberN/A
Device Catalogue Number10491379
Device Lot Number33688386
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 Received11/30/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/24/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-