• 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 12/22/2015
Event Type  malfunction  
Manufacturer Narrative
A siemens customer service engineer (cse) went on site and performed a system inspection and found no system issues that may have attributed to the reagent lot to lot correlation result variability. There were no related system errors observed, no other issues with other tests, and the ca 19-9 reagent appeared to be homogenous. The customer noted that the samples were refrigerated for a maximum of 120 hours then frozen 5-6 days before being repeated in the patient correlation, and may be a contributing factor. The cause for the advia centaur xp reagent lot to lot correlation result variability is unknown. No conclusion can be drawn. The advia centaur xp ca19-9 reagent lot 372 and lot 374 are performing within specifications. The specimen collection and handling section of the instruction for use ifu) states: "the following recommendations for handling and storing blood samples are furnished by the clinical and laboratory standards institute (clsi, formerly nccls): · collect all blood samples observing universal precautions for venipuncture. · allow samples to clot adequately before centrifugation. · keep tubes stoppered and upright at all times. · do not use samples that have been stored at room temperature for longer than 8 hours. · tightly cap and refrigerate specimens at 2° to 8°c if the assay is not completed within 8 hours. · freeze samples at or below -20°c if the sample is not assayed within 48 hours. · freeze samples only once and mix thoroughly after thawing. " the limitations section of the instructions for use (ifu) states: "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. " the instrument is performing within specifications.
 
Event Description
Discordant advia centaur xp ca 19-9 results were observed by the customer when performing a reagent lot (372) to new reagent lot (374) patient correlation study. The patient samples were run on the advia centaur xp with the new reagent lot (374), and then repeated on the advia centaur xp, and advia centaur with the original reagent lot (372). The advia centaur xp and advia centaur correlation results for reagent lot (372) were observed to be lower compared to the new reagent lot (374). The customer noted that the physician(s) had not questioned any of the originally reported ca 19-9 patient results tested with the original reagent lot (372), and the correlation results from reagent lot (374) were not reported. There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp ca 19-9 correlation study results.
 
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 Key5414604
MDR Text Key37624124
Report Number1219913-2016-00021
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
Remedial Action Inspection
Type of Report Initial
Report Date 01/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Technologist
Device Expiration Date04/02/2016
Device Model NumberN/A
Device Catalogue Number10491379
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 Received01/13/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-