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

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 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp ca19-9 results is unknown.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.The instrument is performing within specifications.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "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 discordant high advia centaur xp ca 19-9 result was obtained for a patient sample.The patient sample was tested on the advia centaur xp ca 19-9 reagent lot 382 and lot 384 and the results remained high.The high results were discordant with the negative results from two alternate methods.Ambulatory patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00195 on october 31, 2016.On 11/14/2016 additional information: siemens healthcare diagnostics received the patient sample for further testing and investigation.The patient sample was run with the advia centaur xp, dimension vista ca19-9, and immulite 2000 platforms.The patient sample was also treated with scantibodies heterophilic blocking tubes (hbt).The hbt sample was then run on the advia centaur xp and the dimension vista.There was not sufficient sample volume to be run on the immulite 2000.Lot #s used when testing the patient sample: advia centaur xp ca19-9 lot 384; dimension vista ca19-9 lot 16133bb; immulite 2000 ca19-9 lot 321.Heterophilic blocking tube.Ca19-9 results (u/ml): (b)(6).The patient sample recovered >30% difference between the neat and hbt treated sample on both the advia centaur xp and the dimension vista platforms.The advia centaur xp ca 19-9 result dropping from 153 u/ml to 47 u/ml after treatment with an hbt indicates heterophilic antibodies are elevating the result of this sample with the advia centaur xp ca 19-9 assay.The cause for the discordant advia centaur xp ca19-9 results is heterophilic antibodies.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "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.".

• Brand Name: ADVIA CENTAUR XP CA 19-9 ASSAY
• Type of Device: IMMUNOLOGICAL 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 Key: 6066629
• MDR Text Key: 58818957
• Report Number: 1219913-2016-00195
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR