MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 15-3 ASSAY; CA 15-3 IMMUNOASSAY

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 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse found reagent probe 3 obstructed.The probe was slightly bent but would not have compromised (b)(6) results.The quality control was in range.The cause for the discordant advia centaur xp (b)(6) results is unknown.Possible fibrin or particulate matter in the sample.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics: -samples are free of fibrin or other particulate matter.Remove particulates by centrifugation at 1000 x g for 15-20 minutes.-samples are free of bubbles." the ifu states in the limitation section: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

(b)(6) advia centaur xp (b)(6) results were obtained for a patient sample.The initial result obtained failed the customer's delta check.The patient sample was then repeated twice.The results were not reported.The patient sample was repeated on the second advia centaur xp.This result was similar to the third result from the first advia centaur xp and was reported out.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the (b)(6) results.

• Brand Name: ADVIA CENTAUR XP CA 15-3 ASSAY
• Type of Device: CA 15-3 IMMUNOASSAY
• 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: 5229300
• MDR Text Key: 31393170
• Report Number: 1219913-2015-00170
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2015
• 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