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

Model Number N/A

Device Problem Calibration Problem (2890)

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

Event Date 04/16/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens performed an internal investigation.Siemens determined that some advia centaur systems (b)(4) 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 (b)(4) problem.No further action required.

Event Description

The customer observed calibration failures due to high slope results exceeding defined ranges on two freshly opened reagent readypacks of advia centaur cp (b)(4) lot 043156.Acceptable calibration was obtained with when customer used another reagent readypack of the same lot.The two readypacks with failing calibrations were not used for sample measurement.There was no report of adverse health consequences due to the failed calibrations.

Manufacturer Narrative

Siemens filed initial mdr 121993-2015-00179 on november 18, 2015.On 11/19/2015 - correction: section of the initial mdr had the incorrect date.The correct date is (b)(6) 2015.

• Brand Name: ADVIA CENTAUR CP 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: 5234159
• MDR Text Key: 31571342
• Report Number: 1219913-2015-00179
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012357
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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