MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR

Device Problem Low Test Results (2458)

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

Event Date 06/15/2015

Event Type  malfunction  

Event Description

A discordant, falsely low cancer antigen 19-9 (ca 19-9) result was obtained on one patient sample on an advia centaur instrument.The discordant result was reported to the physician(s), who questioned it.The sample was diluted with a 1:10 dilution factor and was tested on the same instrument, resulting higher.The corrected result 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 19-9 result.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse performed a total service call but could not find an instrument malfunction.The quality controls were within the acceptable ranges.The cause of the discordant, falsely low ca 19-9 result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2432235-2015-00319 was filed on july 8, 2015.A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse performed a total service call but could not find an instrument malfunction.The quality controls were within the acceptable ranges.The cause of the discordant, falsely low ca 27.29 result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Corrected information (10/18/2016): the initial mdr states the method name as cancer antigen 19-9.The correct method name is cancer antigen 27.29.

Event Description

A discordant, falsely low cancer antigen 27.29 (ca 27.29) result was obtained on one patient sample on an advia centaur instrument.The discordant result was reported to the physician(s), who questioned it.The sample was diluted with a 1:10 dilution factor and was tested on the same instrument, resulting higher.The corrected result 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.

• Brand Name: ADVIA CENTAUR
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4899350
• MDR Text Key: 6829184
• Report Number: 2432235-2015-00319
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1