MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR BR (27.29)

Model Number ADVIA CENTAUR BR (27.29)

Device Problems Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse performed calibration and ran quality controls, which were acceptable.The customer began testing their ca 27.29 samples on an alternate advia centaur xp instrument.The cause of the discordant, falsely low ca 27.29 result on one patient sample is unknown.Siemens healthcare diagnostics is investigating the issue.

Event Description

A discordant, falsely low cancer antigen 27.29 (ca 27.29) result was obtained on one patient sample on an advia centaur xp instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate advia centaur xp instrument, resulting higher and matching the clinical picture.It is unknown if the repeat result obtained on an alternate advia centaur xp was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ca 27.29 result.

Manufacturer Narrative

The initial mdr 2432235-2016-00081 was filed on february 17, 2016.Additional information (02/23/2016): a siemens customer care center (ccc) specialist followed up with the customer.The customer is satisfied with the performance of this instrument and the assays being run on it.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2432235-2016-00081 was filed on february 17, 2016.The first supplemental mdr 2432235-2016-00081_s1 was filed on march 18, 2016.Additional information (03/03/2017): siemens healthcare diagnostics has confirmed the potential for the advia centaur (b)(4) assay to interfere with the br (ca 27.29) assay on the advia centaur, advia centaur xp and advia centaur xpt systems.Siemens issued ufsn cc 17-11.A.Ous (march 2017) and umdr cc 17-11.A.Us (march 08, 2017) informing the customer of (b)(4) assay interference with the br (ca 27.29) assay.This issue affects all current and future lots of advia centaur systems br reagents until a solution is implemented.Instructions on actions to be taken are provided in the customer communication.

• Brand Name: ADVIA CENTAUR BR (27.29)
• Type of Device: ADVIA CENTAUR BR (27.29)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1219913; 333 coney st. e; walpole MA 02032
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5442282
• MDR Text Key: 38414129
• Report Number: 2432235-2016-00081
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR BR (27.29)
• Device Lot Number: 27247215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1219913-03/08/2017-003-C
• Patient Sequence Number: 1