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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT 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 06/21/2016
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant advia centaur xp ca19-9 results with the alternate method is unknown. Siemens has requested that the sample be tested with a heterophilic blocking tube to determine if heterophilic antibodies are present in the sample. The interpretation of results section of the instructions for use (ifu) 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 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 instructions for use contains the following: "warning: 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 (b)(4). Assays using antibodies other than 1116-ns-19-9 may give different results. ".
 
Event Description
Customer observed an elevated advia centaur xpt ca 19-9 result that did not confirm on two alternate methods. The elevated result was confirmed on a second advia centaur. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur ca 19-9 results.
 
Manufacturer Narrative
Mdr 1219913-2016-00117 was filed on july 11, 2016 reporting elevated advia centaur xpt ca 19-9 results that did not confirm on two alternate methods. August 12, 2016: siemens received the sample and the sample was tested with two lots of advia centaur xpt ca 19-9 reagent lots (052382 and 052378). The sample was tested both neat and after treatment with heterophilic blocking tubes (hbt). Neat result: lot 052382 - 425 u/ml, lot 052378: 338 u/ml. After treatment with hbt: lot 052382: 24 u/ml. The elevated results confirm what the customer observed. The reduced value obtained after treatment with hbt indicate the elevated results are due to heterophilic interference. The limitations section of the instructions for use states: " heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. " no further investigation is required.
 
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Brand NameADVIA CENTAUR XPT 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 Key5783594
MDR Text Key49236492
Report Number1219913-2016-00117
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 07/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/19/2017
Device Model NumberN/A
Device Catalogue Number10491379
Device Lot Number052382
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 Received08/12/2016
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

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