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 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.

• 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.; 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 Key: 5414604
• MDR Text Key: 37624124
• Report Number: 1219913-2016-00021
• 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

• 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 Received: 02/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/02/2016
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 372
• 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: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial