• 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 06/29/2016
Event Type  malfunction  
Manufacturer Narrative
The cause for the falsely low advia centaur xp ca 19-9 result is unknown. Siemens had the same patient sample retested at two other laboratories. For one laboratory, the patient sample was tested on an advia centaur xpt and the ca 19-9 result was lower. For the other laboratory, the sample was tested on a siemens immulite 2000, and the ca 19-9 result was higher. Siemens is investigating. The warning section of the instructions for use (ifu) states: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc. Assays using antibodies other than 1116-ns-19-9 may give different results. " the limitations section of the instructions for use (ifu) 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 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. ".
 
Event Description
A falsely low advia centaur xp ca 19-9 result was reported by the customer, and considered discordant compared to a higher alternate ca 19-9 test method result. The customer had retested the patient sample at a separate facility with an alternate ca 19-9 test method and the result was higher. The same patient sample was sent to two other laboratories for further ca 19-9 testing. For one laboratory, the patient sample was tested on an advia centaur xpt and the ca 19-9 result was lower. For the other laboratory, the sample was tested on an alternate ca 19-9 test method, and the result was higher. It is unknown if a corrected report was issued by the customer. There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp ca 19-9 result.
 
Manufacturer Narrative
Siemens filed the initial mdr 1219913-2016-00128 on 07/29/2016 for a falsely low advia centaur xp ca 19-9 patient result. On 09/07/2016 - additional information: the cause for the falsely low advia centaur xp ca 19-9 patient result in unknown. The patient sample is not available for further investigation. No conclusion can be drawn. Additional customer contact information. (b)(6). The warning section of the instructions for use (ifu) states: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc. Assays using antibodies other than 1116-ns-19-9 may give different results. " the limitations section of the instructions for use (ifu) 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 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. " the instrument is performing within specifications.
 
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
e. walpole MA 02032
Manufacturer Contact
stephen perry
333 coney street
e. walpole, MA 02032
5086604163
MDR Report Key5835106
MDR Text Key50818021
Report Number1219913-2016-00128
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Technologist
Device Expiration Date01/09/2017
Device Model NumberN/A
Device Catalogue Number10491379
Device Lot Number382
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 Received09/07/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-