MAUDE Adverse Event Report: SIEMENS HEATHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA15-3 ASSAY; CHEMILUMINESCENCE IMMUNO ASSAY KIT FOR THE DETERMINATION OF CA 15-3 ANTIGEN

Model Number N/A

Device Problem Failure to Calibrate (2440)

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

Event Date 01/12/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens performed an internal investigation.Siemens determined that some advia centaur systems ca15-3 reagent readypacks from lot 043156 fail to calibrate due to high slope caused by low relative light units (rlu) output while most reagent readypacks lot 043156 result in acceptable calibration.Customers are not able to perform quality control (qc) or report results due to the calibration failures when an affected readypack is used.Root cause was not determined prior to lot expiration, and the issue does not appear to be a systemic ca15-3 problem.No further action required.

Event Description

Siemens personnel observed calibration failures due to slope results exceeding defined ranges on two different reagent readypacks of advia centaur xp ca15-3 lot 043156.Acceptable calibration results were observed with the use of different reagent readypacks of the same lot.Readypacks with failed calibrations had lower observed relative light units (rlus).There was no report of adverse health consequences due to the failed calibrations.

• Brand Name: ADVIA CENTAUR XP CA15-3 ASSAY
• Type of Device: CHEMILUMINESCENCE IMMUNO ASSAY KIT FOR THE DETERMINATION OF CA 15-3 ANTIGEN
• Manufacturer (Section D): SIEMENS HEATHCARE 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 ; 5086685000
• MDR Report Key: 5233239
• MDR Text Key: 31529979
• Report Number: 1219913-2015-00178
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/09/2015

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: 04/08/2015
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 043156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• 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