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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating. The interpretation of results section of the instructions for use 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 instructions for use 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 ca19-9 can be observed in patients with nonmalignant diseases. Measurements of ca19-9 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. " mdr 1219913-2019-00266 was filed for the same event for the advia centaur xpt ca19-9 repeat result.

Event Description

A customer observed discordant high results for a patient between advia centaur xpt ca19-9 and an alternate testing platform. The initial result was reported and questioned by the physician. The sample was retested on the same advia centaur xpt on the same day and was also tested with an alternate method on the same day. A corrected report was issued based on the alternate method test result. All controls were in acceptable ranges. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca19-9 results.

• Brand Name: ADVIA CETNAUR XPT CA 19-9 IMMUNOASSAY
• 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; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5086608576
• MDR Report Key: 9416906
• MDR Text Key: 208591977
• Report Number: 1219913-2019-00256
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/08/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 96919449
• 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 Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial