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

Model Number ADVIA CENTAUR XP

Device Problem Low Test Results (2458)

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

Event Date 01/19/2015

Event Type  malfunction  

Event Description

A discordant, falsely low cancer antigen 125 (ca 125) result was obtained on one patient sample on an advia centaur xp instrument.The discordant result was reported to the physician(s), who questioned it.A different sample from the patient was tested on the same instrument, resulting higher and matching the patient's clinical history.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ca 125 result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse performed a total service call.Precision testing was run, which resulted within range.The cause of the discordant, falsely low ca 125 result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2432235-2015-00081 was filed on february 16th, 2015.Additional information (02/18/15): the customer provided the corrected result, which was reported to the physician(s).Corrected information (02/18/15): the corrected result was obtained on the same patient sample and not on a different sample as was stated in the initial mdr filing.

Event Description

The corrected result, which was reported to the physician(s) was 39,038 u/ml.The instrument is set up to auto-dilute ca 125 results greater than 450, and this result was obtained upon dilution on the same instrument.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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 ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4519504
• MDR Text Key: 20153397
• Report Number: 2432235-2015-00081
• Device Sequence Number: 1
• Product Code: LTK
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2011
• 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