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 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp ca19-9 results is unknown.The customer did not run any other patient samples with lot 052384 and lot 052388.The customer has accepted ca19-9 lot 052388 for use.No results were questioned by physicians for lot 052384.The patient sample is not available for further testing and investigation at the manufacturer site.The instrument is performing within specifications.No further evaluation of the device is required.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.".

Event Description

A discordant high advia centaur xp ca 19-9 result was obtained for a patient sample during lot to lot correlation.The correlation run was between reagent lot 052384 and lot 052388.The results showed greater than 30% difference.The reagent lot 052388 was recalibrated and the patient sample was repeated.The result was higher than the initial result from lot 052384.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

• 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: 6038229
• MDR Text Key: 57811824
• Report Number: 1219913-2016-00185
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 052388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• 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